The following data is part of a premarket notification filed by Siemens Medical Solution, Inc. Usa with the FDA for Somatom Emotion 16.
| Device ID | K050297 |
| 510k Number | K050297 |
| Device Name: | SOMATOM EMOTION 16 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SIEMENS MEDICAL SOLUTION, INC. USA 51 VALLEY STREAM PKWY. E50 Malvern, PA 19355 |
| Contact | Debra Peacock |
| Correspondent | Debra Peacock SIEMENS MEDICAL SOLUTION, INC. USA 51 VALLEY STREAM PKWY. E50 Malvern, PA 19355 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-07 |
| Decision Date | 2005-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869013114 | K050297 | 000 |
| 04056869010304 | K050297 | 000 |