Part 868 Subpart B—Diagnostic Devices
FDA submissions for Part 868 Subpart B—Diagnostic Devices in the Anesthesiology (AN) review panel, including product codes and regulations.
Section range: §§ 868.1030–868.1985
CFR Part: 868
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| BXL | Algesimeter, Manual | 868.1030 | 1 | 1 |
| BSI | Algesimeter, Powered | 868.1040 | 2 | 0 |
| JEG | Analyzer, Gas, Argon, Gaseous-Phase | 868.1075 | 2 | 1 |
| CBT | Arterial Blood Sampling Kit | 868.1100 | 1 | 58 |
| OFZ | Blood Specimen Collection Kit (Excludes Hiv Testing) | 868.1100 | 1 | 0 |
| JED | Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling | 868.1120 | 3 | 0 |
| CCC | Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling | 868.1150 | 2 | 15 |
| CBZ | Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling | 868.1170 | 2 | 10 |
| CCE | Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling | 868.1200 | 2 | 23 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 868.1400 | 2 | 304 |
| OGK | Orotracheal Intubation Guide Kit | 868.1400 | 2 | 0 |
| CCJ | Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase | 868.1430 | 2 | 27 |
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | 868.1500 | 2 | 22 |
| NHO | Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | 868.1500 | 2 | 0 |
| NHP | Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | 868.1500 | 2 | 1 |
| NHQ | Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | 868.1500 | 2 | 0 |
| QEB | Ventilatory Electrical Impedance Tomograph | 868.1505 | 2 | 6 |
| KGK | Gas, Collecting Vessel | 868.1575 | 1 | 2 |
| CBS | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | 868.1620 | 2 | 17 |
| BSE | Analyzer, Gas, Helium, Gaseous-Phase | 868.1640 | 2 | 3 |
| JEF | Analyzer, Gas, Neon, Gaseous-Phase | 868.1670 | 2 | 0 |
| CCI | Analyzer, Gas, Nitrogen, Gaseous-Phase | 868.1690 | 2 | 2 |
| CBR | Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | 868.1700 | 2 | 5 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 868.1720 | 2 | 121 |
| BZL | Computer, Oxygen-Uptake | 868.1730 | 2 | 33 |
| CCM | Plethysmograph, Pressure | 868.1750 | 2 | 11 |
| JEH | Plethysmograph, Volume | 868.1760 | 2 | 11 |
| BXR | Meter, Airway Pressure (Inspiratory Force) | 868.1780 | 2 | 6 |
| BXQ | Rhinoanemometer (Measurement Of Nasal Decongestion) | 868.1800 | 2 | 12 |
| BZG | Spirometer, Diagnostic | 868.1840 | 2 | 228 |
| PNV | Impedance Measuring Device Utilizing Oscillation Techniques | 868.1840 | 2 | 4 |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | 868.1850 | 2 | 61 |
| BZH | Meter, Peak Flow, Spirometry | 868.1860 | 2 | 79 |
| BXW | Calibrator, Volume, Gas | 868.1870 | 1 | 6 |
| BZC | Calculator, Pulmonary Function Data | 868.1880 | 2 | 90 |
| BTY | Calculator, Predicted Values, Pulmonary Function | 868.1890 | 2 | 63 |
| NDC | Calculator, Drug Dose | 868.1890 | 2 | 53 |
| PDT | Burn Resuscitation Decision Support Software | 868.1890 | 2 | 2 |
| PHY | Sparse Sample Pk Profile And Dosing Software | 868.1890 | 2 | 0 |
| BZM | Calculator, Pulmonary Function Interpretor (Diagnostic) | 868.1900 | 2 | 26 |
| PHZ | Abnormal Breath Sound Device | 868.1900 | 2 | 6 |
| BZW | Stethoscope, Esophageal | 868.1910 | 1 | 13 |
| BZT | Stethoscope, Esophageal, With Electrical Conductors | 868.1920 | 2 | 46 |
| BZS | Stethoscope Head | 868.1930 | 1 | 3 |
| JFE | Valve, Switching (Ploss) | 868.1965 | 1 | 0 |
| BXA | Analyzer, Gas, Water Vapor, Gaseous-Phase | 868.1975 | 1 | 2 |
| QRG | Ultrasound Guided Nerve Block Assist | 868.1980 | 2 | 3 |
| QXD | Spinal Imaging System For Neuraxial Procedures | 868.1985 | 2 | 1 |
