Part 868 Subpart C—Monitoring Devices
FDA submissions for Part 868 Subpart C—Monitoring Devices in the Anesthesiology (AN) review panel, including product codes and regulations.
Section range: §§ 868.2025–868.2900
CFR Part: 868
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| CBA | Monitor, Air Embolism, Ultrasonic | 868.2025 | 2 | 1 |
| QVE | Adjunctive Pain Measurement Device For Anesthesiology | 868.2200 | 2 | 1 |
| QVT | Monitor For Opioid Induced Impairment Of Oxygenation | 868.2250 | 2 | 1 |
| CCN | Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge | 868.2300 | 1 | 9 |
| BYM | Tube, Thorpe, Uncompensated | 868.2320 | 1 | 1 |
| CAX | Flowmeter, Tube, Thorpe, Back-Pressure Compensated | 868.2340 | 1 | 24 |
| BXY | Flowmeter, Calibration, Gas | 868.2350 | 1 | 7 |
| BZQ | Monitor, Breathing Frequency | 868.2375 | 2 | 174 |
| MNR | Ventilatory Effort Recorder | 868.2375 | 2 | 161 |
| PRK | Device Indicating An Exhalation Event | 868.2375 | 2 | 1 |
| FLS | Monitor, Apnea, Facility Use | 868.2377 | 2 | 16 |
| NPF | Monitor, Apnea, Home Use | 868.2377 | 2 | 2 |
| QZW | Over-The-Counter Device To Assess Risk Of Sleep Apnea | 868.2378 | 2 | 2 |
| MRP | Analyzer, Nitric Oxide | 868.2380 | 2 | 1 |
| MRQ | Analyzer, Nitrogen Dioxide | 868.2385 | 2 | 0 |
| PUG | Analyzer, Nitrogen Dioxide, Exempt | 868.2385 | 2 | 0 |
| JEZ | Monitor, Lung Water Measurement | 868.2450 | 3 | 1 |
| LKD | Monitor, Carbon-Dioxide, Cutaneous | 868.2480 | 2 | 17 |
| KLK | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | 868.2500 | 2 | 47 |
| LPP | Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia | 868.2500 | 2 | 2 |
| JAX | Pneumotachometer | 868.2550 | 2 | 8 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 868.2600 | 2 | 78 |
| BXH | Gauge, Gas Pressure, Cylinder/Pipeline | 868.2610 | 1 | 4 |
| PXE | Pressure Monitoring (Air/Gas) Kit | 868.2610 | 1 | 0 |
| BXX | Calibrator, Pressure, Gas | 868.2620 | 1 | 10 |
| CAN | Regulator, Pressure, Gas Cylinder | 868.2700 | 1 | 55 |
| ECX | Cylinder, Compressed Gas, And Valve | 868.2700 | 1 | 13 |
| BXM | Stimulator, Nerve, Ac-Powered | 868.2775 | 2 | 4 |
| BXN | Stimulator, Nerve, Battery-Powered | 868.2775 | 2 | 63 |
| KOI | Stimulator, Nerve, Peripheral, Electric | 868.2775 | 2 | 29 |
| BYR | Transducer, Gas Pressure, Differential | 868.2875 | 1 | 3 |
| BXP | Transducer, Gas Flow | 868.2885 | 1 | 7 |
| BXO | Transducer, Gas Pressure | 868.2900 | 1 | 2 |
