The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Somatom Force.
Device ID | K133589 |
510k Number | K133589 |
Device Name: | SOMATOM FORCE |
Classification | System, X-ray, Tomography, Computed |
Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
Contact | Kimberly Mangum |
Correspondent | Kimberly Mangum SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-11-22 |
Decision Date | 2014-04-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04056869006956 | K133589 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SOMATOM FORCE 79142144 4570526 Live/Registered |
Siemens Healthcare GmbH 2013-11-20 |