The following data is part of a premarket notification filed by Siemens Medical Solutions Usa Inc. with the FDA for Syngo Brevis.
Device ID | K090038 |
510k Number | K090038 |
Device Name: | SYNGO BREVIS |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | SIEMENS MEDICAL SOLUTIONS USA INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 |
Contact | Judith Campbell |
Correspondent | Judith Campbell SIEMENS MEDICAL SOLUTIONS USA INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-01-06 |
Decision Date | 2009-04-28 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SYNGO BREVIS 79079496 3924868 Live/Registered |
Siemens Healthcare GmbH 2010-01-25 |