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 |