SIMVIEW(TM) 3000— 510(k) K946053

Name: FDA 510(k) clearance K946053
Creator: U.S. Food and Drug Administration
Published: 1995-03-31

Substantially Equivalent

Siemens Medical Solutions USA, Inc.

FDA 510(k) clearance K946053 for SIMVIEW(TM) 3000, Substantially Equivalent on 1995-03-31. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.

Clearance details

Applicant: Siemens Medical Solutions USA, Inc.
Product code: Code KPQ
Device class: Class 2
Regulation: 21 CFR 892.5840
Advisory panel: Radiology
Date received: 1994-12-12
Decision date: 1995-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

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