The following data is part of a premarket notification filed by Winprobe Corporation with the FDA for Ultravision 2 Diagnostic Ultrasound System.
| Device ID | K150580 |
| 510k Number | K150580 |
| Device Name: | UltraVision 2 Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | WINPROBE CORPORATION 11770 US HIGHWAY 1, SUITE 405E Palm Beach Gradens, FL 33408 |
| Contact | Rose Malchow |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-03-09 |
| Decision Date | 2015-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B616UVXS0 | K150580 | 000 |
| B616UVXR0 | K150580 | 000 |
| B616UVXP0 | K150580 | 000 |