HEP
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Monitor, Blood-Flow, Ultrasonic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2660
- Medical specialty
- Obstetrics/Gynecology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SONOTRAX SERIES ULTRASONIC POCKET DOPPLER (K101960) | Edan Instruments, Inc. | 2010-08-10 |
| BABYCARE (K023082) | Bionet Company, Ltd. | 2003-03-03 |
| ULTRACELL INSTRUMENT WIPE (K920353) | Ultracell Medical Technologies, Inc. | 1992-09-15 |
| POCKET DOP 3 (K910462) | Imex Medical Systems, Inc. | 1991-06-24 |
Track HEP automatically
Every clearance here is in the API, with alerts when new ones post.