HEK — Monitor, Heart Sound, Fetal, Ultrasonic Class II
FDA Device Classification
Classification Details
- Product Code
- HEK
- Device Class
- Class II
- Regulation Number
- 884.2660
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K142769 | icare newlife technologies | Fetal Doppler | March 20, 2015 |
| K060410 | summit doppler systems | ECHOHEART TRANSVAGINAL DOPPLER PROBE | April 10, 2006 |
| K902190 | advanced medical systems | FETAL PULSE DETECTOR MODEL DOP-1 | October 22, 1990 |
| K883334 | diagnosis related systems | BIODOP(TM) | December 15, 1988 |
| K771211 | terumo america | DOPPLER (UTD-5 & UTD-6) | July 14, 1977 |