QUEST PET IMAGING SYSTEM— 510(k) K973396

Name: FDA 510(k) clearance K973396
Creator: U.S. Food and Drug Administration
Published: 1998-01-21

Substantially Equivalent

Ugm Medical Systems, Inc.

FDA 510(k) clearance K973396 for QUEST PET IMAGING SYSTEM, Substantially Equivalent on 1998-01-21. Applicant: Ugm Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Ugm Medical Systems, Inc.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 1997-08-25
Decision date: 1998-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Philadelphia, PA, US

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