Panels › Obstetrics/Gynecology › Product code HEP · Class 2
Monitor, Blood-Flow, Ultrasonic
Regulation 884.2660
0510(k)s in 12 months (4 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in HEP
| Company | 510(k)s | Recalls |
|---|---|---|
| Bionet Company, Ltd. | 1 | 0 |
| Edan Instruments, Inc. | 1 | 0 |
| Imex Medical Systems, Inc. | 1 | 0 |
| Ultracell Medical Technologies, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 10, 2010 | K101960 | SONOTRAX SERIES ULTRASONIC POCKET DOPPLER Edan Instruments, Inc., CN | HEP |
| Mar 3, 2003 | K023082 | BABYCARE Bionet Company, Ltd. | HEP |
| Sep 15, 1992 | K920353 | ULTRACELL INSTRUMENT WIPE Ultracell Medical Technologies, Inc. | HEP |
| Jun 24, 1991 | K910462 | POCKET DOP 3 Imex Medical Systems, Inc. | HEP |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.