Panels › Obstetrics/Gynecology › Product code HEK · Class 2
Monitor, Heart Sound, Fetal, Ultrasonic
Regulation 884.2660
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in HEK
| Company | 510(k)s | Recalls |
|---|---|---|
| Advanced Medical Systems, Inc. | 1 | 0 |
| Diagnosis Related Systems, Inc. | 1 | 0 |
| Icare Newlife Technologies, Inc. | 1 | 0 |
| Summit Doppler Systems, Inc. | 1 | 0 |
| Terumo America, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 20, 2015 | K142769 | Fetal Doppler Icare Newlife Technologies, Inc., CN | HEK |
| Apr 10, 2006 | K060410 | ECHOHEART TRANSVAGINAL DOPPLER PROBE Summit Doppler Systems, Inc. | HEK |
| Oct 22, 1990 | K902190 | FETAL PULSE DETECTOR MODEL DOP-1 Advanced Medical Systems, Inc. | HEK |
| Dec 15, 1988 | K883334 | BIODOP(TM) Diagnosis Related Systems, Inc. | HEK |
| Jul 14, 1977 | K771211 | DOPPLER (UTD-5 & UTD-6) Terumo America, Inc. | HEK |
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