The following data is part of a premarket notification filed by Summit Doppler Systems, Inc. with the FDA for Lifedop Model, L350r.
| Device ID | K090499 |
| 510k Number | K090499 |
| Device Name: | LIFEDOP MODEL, L350R |
| Classification | Monitor, Fetal Doppler Ultrasound |
| Applicant | SUMMIT DOPPLER SYSTEMS, INC. 4680 TABLE MOUNTAIN DR #150 Golden, CO 80403 |
| Contact | Ken Jarrell |
| Correspondent | Dawn Tibodeau TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | MAA |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-02-25 |
| Decision Date | 2009-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888937010244 | K090499 | 000 |
| 00888937002386 | K090499 | 000 |
| 00888937002393 | K090499 | 000 |
| 00888937002409 | K090499 | 000 |
| 00888937002416 | K090499 | 000 |
| 00888937002423 | K090499 | 000 |
| 00888937002430 | K090499 | 000 |
| 00888937002447 | K090499 | 000 |
| 00888937010190 | K090499 | 000 |
| 00888937010206 | K090499 | 000 |
| 00888937010213 | K090499 | 000 |
| 00888937010220 | K090499 | 000 |
| 00888937010237 | K090499 | 000 |
| 00888937002379 | K090499 | 000 |