The following data is part of a premarket notification filed by Summit Doppler Systems, Inc. with the FDA for Echoheart Transvaginal Doppler Probe.
| Device ID | K060410 |
| 510k Number | K060410 |
| Device Name: | ECHOHEART TRANSVAGINAL DOPPLER PROBE |
| Classification | Monitor, Heart Sound, Fetal, Ultrasonic |
| Applicant | SUMMIT DOPPLER SYSTEMS, INC. 4620 TECHNOLOGY DR. UNIT 100 Golden, CO 80403 |
| Contact | Ken Jarrell |
| Correspondent | Ken Jarrell SUMMIT DOPPLER SYSTEMS, INC. 4620 TECHNOLOGY DR. UNIT 100 Golden, CO 80403 |
| Product Code | HEK |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-16 |
| Decision Date | 2006-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888937014716 | K060410 | 000 |