The following data is part of a premarket notification filed by Summit Doppler Systems, Inc. with the FDA for Lifedop Doppler.
| Device ID | K024197 |
| 510k Number | K024197 |
| Device Name: | LIFEDOP DOPPLER |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | SUMMIT DOPPLER SYSTEMS, INC. 5350 VIVIAN ST., SUITE A Arvada, CO 80002 -1957 |
| Contact | Ken Jarrell |
| Product Code | KNG |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-12-20 |
| Decision Date | 2003-01-03 |
| Summary: | summary |