The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Symbia T16, Symbia Intevo 16 And Symbia Intevo Bold.
Device ID | K173023 |
510k Number | K173023 |
Device Name: | Symbia T16, Symbia Intevo 16 And Symbia Intevo Bold |
Classification | System, Tomography, Computed, Emission |
Applicant | Siemens Medical Solutions USA, Inc. 2501 N. Barrington Road Hoffman Estates, IL 60192 |
Contact | Tabitha Estes |
Correspondent | Tabitha Estes Siemens Medical Solutions USA, Inc. 2501 N. Barrington Road Hoffman Estates, IL 60192 |
Product Code | KPS |
CFR Regulation Number | 892.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-28 |
Decision Date | 2017-11-17 |
Summary: | summary |