VPC-94 ULTRA HIGH ENERGY COLLIMATERS MODEL NUMBERS 480-685-9402— 510(k) K981352

Name: FDA 510(k) clearance K981352
Creator: U.S. Food and Drug Administration
Published: 1998-07-13

Substantially Equivalent

Ge Medical Systems F.I. Haifa

FDA 510(k) clearance K981352 for VPC-94 ULTRA HIGH ENERGY COLLIMATERS MODEL NUMBERS 480-685-9402, Substantially Equivalent on 1998-07-13. Applicant: Ge Medical Systems F.I. Haifa. Device class: 2.

Clearance details

Applicant: Ge Medical Systems F.I. Haifa
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 1998-04-14
Decision date: 1998-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haifa, IL

Download summary PDF View on FDA.gov ↗

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