The following data is part of a premarket notification filed by Ultrasonix Medical Corporation with the FDA for Sonix Mdp Ultrasound Scanner.
| Device ID | K080935 |
| 510k Number | K080935 |
| Device Name: | SONIX MDP ULTRASOUND SCANNER |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | UltraSonix Medical Corporation 130-4311 VIKING WAY Richmond, British Columbia, CA V6v 2k9 |
| Contact | Alan Remfry |
| Correspondent | Alan Remfry UltraSonix Medical Corporation 130-4311 VIKING WAY Richmond, British Columbia, CA V6v 2k9 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-02 |
| Decision Date | 2008-08-06 |
| Summary: | summary |