FDA Product Code
FDA Product Code HEP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.2660
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K101960 | SONOTRAX SERIES ULTRASONIC POCKET DOPPLER | Edan Instruments, Inc. | 2010-08-10 | Special | PDF ↗ |
| K023082 | BABYCARE | Bionet Company, Ltd. | 2003-03-03 | Abbreviated | PDF ↗ |
| K920353 | ULTRACELL INSTRUMENT WIPE | Ultracell Medical Technologies, Inc. | 1992-09-15 | Traditional | PDF ↗ |
| K910462 | POCKET DOP 3 | Imex Medical Systems, Inc. | 1991-06-24 | Traditional | PDF ↗ |
Product code HEP · Class II · Obstetrics/Gynecology. Data: openFDA.