The following data is part of a premarket notification filed by Siemens Medical Solutions, Usa, Inc. with the FDA for Symbia Intevo Bold.
Device ID | K162483 |
510k Number | K162483 |
Device Name: | Symbia Intevo Bold |
Classification | System, Tomography, Computed, Emission |
Applicant | SIEMENS MEDICAL SOLUTIONS, USA, INC. 2501 N. BARRINGTON ROAD Hoffman Estates, IL 60192 -2061 |
Contact | Cynthia Busch |
Correspondent | Cynthia Busch SIEMENS MEDICAL SOLUTIONS, USA, INC. 2501 N. BARRINGTON ROAD Hoffman Estates, IL 60192 -2061 |
Product Code | KPS |
CFR Regulation Number | 892.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-09-06 |
Decision Date | 2017-01-09 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SYMBIA INTEVO BOLD 87106806 5242861 Live/Registered |
Siemens Medical Solutions USA, Inc. 2016-07-18 |