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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chamber, Patient Isolation
510(k) Number K080117
Device Name PATIENT ISOLATION UNIT, MODEL G019-1000
Applicant
Gentex Corporation
11525 Sixth St.
Rancho Cucamonga,  CA  91730
Applicant Contact BARRY SHOPE
Correspondent
Gentex Corporation
11525 Sixth St.
Rancho Cucamonga,  CA  91730
Correspondent Contact BARRY SHOPE
Regulation Number880.5450
Classification Product Code
LGM  
Date Received01/17/2008
Decision Date 01/30/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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