The following data is part of a premarket notification filed by Summit Doppler Systems, Inc. with the FDA for Vantage Abi.
| Device ID | K103693 |
| 510k Number | K103693 |
| Device Name: | VANTAGE ABI |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| 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 | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-12-17 |
| Decision Date | 2011-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888937011364 | K103693 | 000 |
| 00888937011357 | K103693 | 000 |