The following data is part of a premarket notification filed by Avotec, Inc. with the FDA for Silent Scan.
Device ID | K921891 |
510k Number | K921891 |
Device Name: | SILENT SCAN |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | AVOTEC, INC. P.O. BOX 1777 Jensen Beach, FL 34958 |
Contact | Paul E Bullwinkel |
Correspondent | Paul E Bullwinkel AVOTEC, INC. P.O. BOX 1777 Jensen Beach, FL 34958 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-04-22 |
Decision Date | 1993-05-13 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SILENT SCAN 85789426 4578332 Live/Registered |
Avotec, Inc. 2012-11-28 |