The following data is part of a premarket notification filed by Summit Doppler Systems, Inc. with the FDA for Lifedop Model 300abi.
| Device ID | K093393 |
| 510k Number | K093393 |
| Device Name: | LIFEDOP MODEL 300ABI |
| Classification | Monitor, Ultrasonic, Nonfetal |
| Applicant | SUMMIT DOPPLER SYSTEMS, INC. 4680 TABLE MOUNTAIN DR #150 Golden, CO 80403 |
| Contact | Ken Jarrell |
| Correspondent | Ken Jarrell SUMMIT DOPPLER SYSTEMS, INC. 4680 TABLE MOUNTAIN DR #150 Golden, CO 80403 |
| Product Code | JAF |
| CFR Regulation Number | 892.1540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-30 |
| Decision Date | 2009-12-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60888937010260 | K093393 | 000 |
| 60888937010253 | K093393 | 000 |
| 40612479199666 | K093393 | 000 |
| 00888937019919 | K093393 | 000 |
| 00888937002362 | K093393 | 000 |
| 00888937002188 | K093393 | 000 |
| 00888937002171 | K093393 | 000 |
| 00888937002089 | K093393 | 000 |
| 00888937002072 | K093393 | 000 |