GE VISION NUCLEAR MEDICINE WORKSTATION— 510(k) K012568

Name: FDA 510(k) clearance K012568
Creator: U.S. Food and Drug Administration
Published: 2001-09-06

Substantially Equivalent

General Electric Co.

FDA 510(k) clearance K012568 for GE VISION NUCLEAR MEDICINE WORKSTATION, Substantially Equivalent on 2001-09-06. Applicant: General Electric Co.. Device class: 2.

Clearance details

Applicant: General Electric Co.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2001-08-09
Decision date: 2001-09-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Twinsburg, OH, US

Download summary PDF View on FDA.gov ↗

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