PATIENT ISOLATION UNIT, MODEL G019-1000— 510(k) K080117

Name: FDA 510(k) clearance K080117
Creator: U.S. Food and Drug Administration
Published: 2009-01-30

Substantially Equivalent

Gentex Corporation

FDA 510(k) clearance K080117 for PATIENT ISOLATION UNIT, MODEL G019-1000, Substantially Equivalent on 2009-01-30. Applicant: Gentex Corporation. Device class: 2.

Clearance details

Applicant: Gentex Corporation
Product code: Code LGM
Device class: Class 2
Regulation: 21 CFR 880.5450
Advisory panel: General Hospital
Date received: 2008-01-17
Decision date: 2009-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Cucamonga, CA, US

Download summary PDF View on FDA.gov ↗

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