510(k) K771211
- Device
- DOPPLER (UTD-5 & UTD-6)
- Applicant
- Terumo America, Inc.
- 510(k) number
- K771211
- Product code
- HEK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-07-14
- Date received
- 1977-07-05
- Regulation
- 884.2660
- Classification name
- Monitor, Heart Sound, Fetal, Ultrasonic
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3020115
- 1216677
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HEK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K142769 | Fetal Doppler | Icare Newlife Technologies, Inc. | 2015-03-20 |
| K060410 | ECHOHEART TRANSVAGINAL DOPPLER PROBE | Summit Doppler Systems, Inc. | 2006-04-10 |
| K902190 | FETAL PULSE DETECTOR MODEL DOP-1 | Advanced Medical Systems, Inc. | 1990-10-22 |
| K883334 | BIODOP(TM) | Diagnosis Related Systems, Inc. | 1988-12-15 |