510(k) K060410
- Device
- ECHOHEART TRANSVAGINAL DOPPLER PROBE
- Applicant
- SUMMIT DOPPLER SYSTEMS, INC.
- 510(k) number
- K060410
- Product code
- HEK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-04-10
- Date received
- 2006-02-16
- Regulation
- 884.2660
- Classification name
- Monitor, Heart Sound, Fetal, Ultrasonic
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KEN JARRELL
- Address
- 4620 Technology Dr. Unit 100 Golden CO US 80403 80403
FDA Registration Numbers#
- 3020115
- 1216677
Source Documents#
Other 510(k) Records For Product Code HEK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K142769 | Fetal Doppler | Icare Newlife Technologies, Inc. | 2015-03-20 |
| K902190 | FETAL PULSE DETECTOR MODEL DOP-1 | Advanced Medical Systems, Inc. | 1990-10-22 |
| K883334 | BIODOP(TM) | Diagnosis Related Systems, Inc. | 1988-12-15 |
| K771211 | DOPPLER (UTD-5 & UTD-6) | Terumo America, Inc. | 1977-07-14 |
Legacy Summary#
summary
FDA Review#
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