The following data is part of a premarket notification filed by Summit Doppler Systems, Inc. with the FDA for Stn Probe.
| Device ID | K101816 |
| 510k Number | K101816 |
| Device Name: | STN PROBE |
| Classification | Transducer, Ultrasonic, Diagnostic |
| 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 | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-30 |
| Decision Date | 2010-08-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888937002010 | K101816 | 000 |
| 00888937001983 | K101816 | 000 |