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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 K102985
Device Name V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS
Applicant
Respironics Inc.
1001 Murry Ridge Lane
Murrysville,  PA  15668
Applicant Contact TAMATHA LEY
Correspondent
Respironics Inc.
1001 Murry Ridge Lane
Murrysville,  PA  15668
Correspondent Contact TAMATHA LEY
Regulation Number868.5895
Classification Product Code
MNT  
Date Received10/07/2010
Decision Date 04/05/2011
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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