UNIVERSIX 190— 510(k) K953402

Name: FDA 510(k) clearance K953402
Creator: U.S. Food and Drug Administration
Published: 1995-08-11

Substantially Equivalent

Philips Medical Systems (Cleveland), Inc.

FDA 510(k) clearance K953402 for UNIVERSIX 190, Substantially Equivalent on 1995-08-11. Applicant: Philips Medical Systems (Cleveland), Inc.. Device class: 1.

Clearance details

Applicant: Philips Medical Systems (Cleveland), Inc.
Product code: Code IXY
Device class: Class 1
Regulation: 21 CFR 892.1880
Advisory panel: Radiology
Date received: 1995-07-20
Decision date: 1995-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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