GAME READY CLASSIC SYSTEM, MODEL 550550— 510(k) K072620

Name: FDA 510(k) clearance K072620
Creator: U.S. Food and Drug Administration
Published: 2007-10-31

Substantially Equivalent

Coolsystems, Inc.

FDA 510(k) clearance K072620 for GAME READY CLASSIC SYSTEM, MODEL 550550, Substantially Equivalent on 2007-10-31. Applicant: Coolsystems, Inc.. Device class: 2.

Clearance details

Applicant: Coolsystems, Inc.
Product code: Code IRP
Device class: Class 2
Regulation: 21 CFR 890.5650
Advisory panel: Physical Medicine
Date received: 2007-09-17
Decision date: 2007-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berkeley, CA, US

Download summary PDF View on FDA.gov ↗

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