Part 880 Subpart C—General Hospital and Personal Use Monitoring Devices
FDA submissions for Part 880 Subpart C—General Hospital and Personal Use Monitoring Devices in the General Hospital (HO) review panel, including product codes and regulations.
Section range: §§ 880.2200–880.2930
CFR Part: 880
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| KPD | Strip, Temperature, Forehead, Liquid Crystal | 880.2200 | 2 | 21 |
| KMI | Monitor, Bed Patient | 880.2400 | 1 | 31 |
| PJO | Fall Prevention Alarm/Sensor Combination Attached Or Unattached | 880.2400 | 1 | 0 |
| PJP | Fall Prevention Alarm/Sensor Attached Only | 880.2400 | 1 | 0 |
| SBO | Bed-Patient Activity Monitoring System | 880.2400 | 1 | 1 |
| FLN | Monitor, Electric For Gravity Flow Infusion Systems | 880.2420 | 2 | 39 |
| CAR | Monitor, Spinal-Fluid Pressure, Electrically Powered | 880.2460 | 2 | 3 |
| FMJ | Manometer, Spinal-Fluid | 880.2500 | 2 | 6 |
| FRI | Scale, Stand-On, Patient | 880.2700 | 1 | 3 |
| FRW | Scale, Patient | 880.2720 | 1 | 48 |
| FQA | Scale, Surgical Sponge | 880.2740 | 1 | 1 |
| LWH | Counter, Sponge, Surgical | 880.2740 | 1 | 15 |
| MRL | Scale, Sponge, Surgical, Electrically-Powered | 880.2740 | 1 | 1 |
| PBZ | Image Processing Device For Estimation Of External Blood Loss | 880.2750 | 2 | 6 |
| FRC | Indicator, Biological Sterilization Process | 880.2800 | 2 | 206 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 880.2800 | 2 | 265 |
| LRT | Indicator, Sterilization | 880.2800 | 2 | 5 |
| MRB | Indicator, Biological, Liquid Chemical Sterilization Process | 880.2800 | 2 | 4 |
| MTC | Indicator, Chemical, Enzymatic, Sterilization Process | 880.2800 | 2 | 2 |
| OCI | Indicator, Physical/Chemical, Storage Temperature | 880.2800 | 2 | 1 |
| QKM | A Chemical Vapor Sterilization Multivariable Chemical Indicator | 880.2800 | 2 | 5 |
| SBE | Digital Physical/Chemical Sterilization Process Sensor | 880.2801 | 2 | 0 |
| OWP | Biological Sterilization Process Indicator With Recombinant-Dna Plasmid | 880.2805 | 2 | 5 |
| QVB | Biological Sterilization Indicator With Indirect Growth Detection | 880.2806 | 2 | 2 |
| FQZ | Thermometer, Clinical Color Change | 880.2900 | 1 | 14 |
| FLL | Continuous Measurement Thermometer | 880.2910 | 2 | 797 |
| OZK | Thermometer, Exhaled Breath | 880.2910 | 2 | 0 |
| PWW | Fever Monitoring Kit | 880.2910 | 2 | 0 |
| PXH | Thermometer Kit | 880.2910 | 2 | 0 |
| SDV | Clinical Electronic Thermometer | 880.2910 | 2 | 0 |
| SDW | Stationary Infrared Thermometer | 880.2910 | 2 | 0 |
| QZA | Body Temperature Sensing Software | 880.2915 | 2 | 2 |
| FLK | Thermometer, Clinical Mercury | 880.2920 | 2 | 33 |
| LHB | Timer, Apgar | 880.2930 | 1 | 2 |
