The following data is part of a premarket notification filed by Ultrasonix Medical Corporation with the FDA for Sonixgps.
| Device ID | K121812 |
| 510k Number | K121812 |
| Device Name: | SONIXGPS |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | UltraSonix Medical Corporation 57 Lazy Brook Rd. Monroe, CT 06468 |
| Contact | Raymond Kelly |
| Correspondent | Raymond Kelly UltraSonix Medical Corporation 57 Lazy Brook Rd. Monroe, CT 06468 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-20 |
| Decision Date | 2013-12-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SONIXGPS 77818812 3901570 Dead/Cancelled |
Ultrasonix Medical Corporation 2009-09-02 |