FDA Product Code
FDA Product Code HEK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.2660
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K142769 | Fetal Doppler | Icare Newlife Technologies, Inc. | 2015-03-20 | Traditional | PDF ↗ |
| K060410 | ECHOHEART TRANSVAGINAL DOPPLER PROBE | Summit Doppler Systems, Inc. | 2006-04-10 | Traditional | PDF ↗ |
| K902190 | FETAL PULSE DETECTOR MODEL DOP-1 | Advanced Medical Systems, Inc. | 1990-10-22 | Traditional | PDF ↗ |
| K883334 | BIODOP(TM) | Diagnosis Related Systems, Inc. | 1988-12-15 | Traditional | PDF ↗ |
| K771211 | DOPPLER (UTD-5 & UTD-6) | Terumo America, Inc. | 1977-07-14 | Traditional | PDF ↗ |
Product code HEK · Class II · Obstetrics/Gynecology. Data: openFDA.