The following data is part of a premarket notification filed by Winprobe Corporation with the FDA for Ultravision 2 Diagnostic Ultrasound System.
| Device ID | K173265 |
| 510k Number | K173265 |
| Device Name: | UltraVision 2 Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | WinProbe Corporation 11770 US Highway 1 Suite 302E Palm Beach Gardens, FL 33408 |
| Contact | Guy Scott |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-10-11 |
| Decision Date | 2017-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840067103593 | K173265 | 000 |
| 00840067103586 | K173265 | 000 |
| 00840067103531 | K173265 | 000 |
| 00840067103487 | K173265 | 000 |
| B616UVXC0 | K173265 | 000 |
| B616UVTKL1440 | K173265 | 000 |
| B616UVTKHL1840 | K173265 | 000 |
| B616UVTKCC520 | K173265 | 000 |