CT Sim Laser System— 510(k) K152303

Substantially Equivalent

Gammex, Inc.

FDA 510(k) clearance K152303 for CT Sim Laser System, Substantially Equivalent on 2015-09-11. Applicant: Gammex, Inc.. Device class: 1.

Clearance details

Applicant: Gammex, Inc.
Product code: Code IWE
Device class: Class 1
Regulation: 21 CFR 892.5780
Advisory panel: Radiology
Date received: 2015-08-14
Decision date: 2015-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Middleton, WI, US

Download summary PDF View on FDA.gov ↗

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