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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
510(k) Number K082660
Device Name V60 VENTILATOR, MODEL V8000
Applicant
RESPIRONICS CALIFORNIA, INC.
2271 COSMOS CT.
CARLSBAD,  CA  92011
Applicant Contact MARA CALER
Correspondent
RESPIRONICS CALIFORNIA, INC.
2271 COSMOS CT.
CARLSBAD,  CA  92011
Correspondent Contact MARA CALER
Regulation Number868.5895
Classification Product Code
MNT  
Date Received09/12/2008
Decision Date 01/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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