The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Somatom Emotion 6 Ct Systems, Somatom Emotion 16.
Device ID | K133424 |
510k Number | K133424 |
Device Name: | SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16 |
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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-11-08 |
Decision Date | 2014-01-17 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04056869010298 | K133424 | 000 |