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 |