SOMATOM Drive
System, X-ray, Tomography, Computed
Siemens Medical Solutions USA, Inc.
The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Somatom Drive.
Pre-market Notification Details
| Device ID | K161196 |
| 510k Number | K161196 |
| Device Name: | SOMATOM Drive |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Siemens Medical Solutions USA, Inc. 65 Valley Stream Parkway Malvern, PA 19355 |
| Contact | Kimberly Mangum |
| Correspondent | Kimberly Mangum Siemens Medical Solutions USA, Inc. 65 Valley Stream Parkway Malvern, PA 19355 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-27 |
| Decision Date | 2016-08-24 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869006970 | K161196 | 000 |
Trademark Results [SOMATOM Drive]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOMATOM DRIVE 79192760 5268373 Live/Registered |
Siemens Healthcare GmbH 2016-08-05 |
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