The following data is part of a premarket notification filed by Ultrasonix Medical Corporation with the FDA for Ultrasonix Ergosonix 500 Ultrasound Scanner.
| Device ID | K020630 |
| 510k Number | K020630 |
| Device Name: | ULTRASONIX ERGOSONIX 500 ULTRASOUND SCANNER |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | UltraSonix Medical Corporation 535-2660 OAK ST. Vancouver, Bc, CA V6h 3z1 |
| Contact | Ken Seto |
| Correspondent | Ken Seto UltraSonix Medical Corporation 535-2660 OAK ST. Vancouver, Bc, CA V6h 3z1 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-26 |
| Decision Date | 2002-06-13 |
| Summary: | summary |