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 |