Classified Devices
Classified Devices
(Classification regulation number followed by classification name)
• 862.1345 — Glucose test system
• 862.2140 — Centrifugal chemistry analyzer for clinical use
• 862.2150 — Continuous flow sequential multiple chemistry analyzer for clinical use
• 862.2160 — Discrete photometric chemistry analyzer for clinical use
• 862.2170 — Micro chemistry analyzer for clinical use
• 868.1150 — Indwelling blood carbon dioxide partial pressure (pC02) analyzer
• 868.1200 — Indwelling blood oxygen partial pressure (p02) analyzer
• 868.1730 — Oxygen-uptake computer
• 868.2375 — Breathing frequency monitor
• 868.2450 — Lung water monitor
• 868.5160 — Gas machine for anesthesia or analgesia
• 868.5330 — Breathing gas mixer
• 868.5400 — Electroanesthesia apparatus
• 868.5440 — Portable oxygen generator
• 868.5470 — Hyperbaric chamber
• 868.5610 — Membrane lung (for long-term pulmonary support)
• 868.5830 — Autotransfusion apparatus
• 868.5880 — Anesthetic vaporizer
• 868.5895 — Continuous ventilator
• 868.5925 — Powered emergency ventilator
• 868.5935 — External negative pressure ventilator
• 868.5955 — Intermittent mandatory ventilation attachment
• 870.1025 — Arrhythmia detector and alarm
• 870.1750 — External programmable pacemaker pulse generator
• 870.3535 — Intra-aortic balloon and control system
• 870.3545 — Ventricular bypass (assist) device
• 870.3600 — External pacemaker pulse generator
• 870.3610 — Implantable pacemaker pulse generator
• 870.3700 — Pacemaker programmers
• 870.4220 — Cardiopulmonary bypass heart-lung machine console
• 870.4320 — Cardiopulmonary bypass pulsatile flow generator
• 870.4330 — Cardiopulmonary bypass on-line blood gas monitor
• 870.4360 — Nonroller-type cardiopulmonary bypass blood pump
• 870.4370 — Roller type cardiopulmonary bypass blood pump
• 870.4380 — Cardiopulmonary bypass pump speed control
• 870.5225 — External counter-pulsating device
• 870.5300 — DC-Defibrillator low energy (including paddles)
• 876.5270 — Implanted electrical urinary continence device
• 876.5630 — Peritoneal dialysis system and accessories
• 876.5820 — Hemodialysis systems and accessories
• 876.5860 — High-permeability hemodialysis system
• 876.5870 — Sorbent hemoperfusion system
• 876.5880 — Isolated kidney perfusion and transport system and accessories
• 880.5130 — Infant radiant warmer
• 880.5400 — Neonatal incubator
• 880.5410 — Neonatal transport incubator
• 880.5725 — Infusion pump
• 882.5820 — Implanted cerebellar stimulator
• 882.5830 — Implanted diaphragmatic/phrenic nerve stimulator
• 882.5840 — Implanted intracerebral/subcortical stimulator for pain relief
882.5850 — Implanted spinal cord stimulator for bladder evacuation
• 882.5860 — Implanted neuromuscular stimulator
• 882.5870 — Implanted peripheral nerve stimulator for pain relief
• 882.5880 — Implanted spinal cord stimulator for pain relief
• 884.1700 — Hysteroscopic insufflator
• 884.1730 — Laparoscopic insufflator
• 884.2660 — Fetal ultrasonic monitor and accessories
The following device classifications include radiation treatment planning systems that are accessories to these device types.
• 892.5050* — Medical charged-particle radiation therapy system
• 892.5300* — Medical neutron radiation therapy system
• 892.5700* — Remote controlled radionuclide-applicator system
• 892.5750* — Radionuclide radiation therapy system
• 892.5900* — X-ray radiation therapy system
*The above-specified device classifications include radiation treatment planning systems that are accessories to these device types.
Post-medical device amendments Class III devices, and devices not yet classified
• Ventilator, high frequency
• Cardioconverter, implantable
• Defibrillator, automatic implantable cardioverter
• Defibrillator, implantable, dual-chamber
• Pulse-generator, dual chamber, implantable
• Pulse-generator, program module
• Pulse-generator, single chamber, sensor-driven, implantable
• Pulse-generator, single chamber
• System, pacing, temporary, acute, internal atrial defibrillation
• Automated blood cell and plasma separator for therapeutic purposes
• Lipoprotein, low density, removal
• Separator for therapeutic purposes, membrane automated blood cell/plasma
• Pump, drug administration, closed loop
• Pump, infusion, implanted, programmable
• Kit, test, alpha-fetoprotein for neural tube defects
• Stimulator, cortical, implanted (for pain)
• Stimulator, electrical, implanted, for Parkinsonian tremor
• Stimulator, sacral nerve, implanted
• Stimulator, spinal cord, totally implanted for pain relief
• Stimulator, subcortical, implanted for epilepsy
• Device, thermal ablation, endometrial
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