The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Somatom Definition, Model As/as+.
Device ID | K081022 |
510k Number | K081022 |
Device Name: | SOMATOM DEFINITION, MODEL AS/AS+ |
Classification | System, X-ray, Tomography, Computed |
Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. E-50 Malvern, PA 19355 |
Contact | Corrine Mcleod |
Correspondent | Corrine Mcleod SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. E-50 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 | 2008-04-10 |
Decision Date | 2008-06-02 |
Summary: | summary |