ISOCAM II (DUAL HEAD GAMMA CAMERA)— 510(k) K964834

Name: FDA 510(k) clearance K964834
Creator: U.S. Food and Drug Administration
Published: 1997-02-28

Substantially Equivalent

Park Medical Systems, Inc.

FDA 510(k) clearance K964834 for ISOCAM II (DUAL HEAD GAMMA CAMERA), Substantially Equivalent on 1997-02-28. Applicant: Park Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Park Medical Systems, Inc.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 1996-12-02
Decision date: 1997-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lachine Quebec, CA

Download summary PDF View on FDA.gov ↗

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