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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, facility use
510(k) Number K110795
Device Name V200 INTELLI-TRAK OPTION
Applicant
RESPIRONICS CALIFORNIA, INC.
3919 WILLIAM PENN HIGHWAY,
SUITE 200
MURRYSVILLE,  PA  15668 -8550
Applicant Contact ROBERT M MARSHALL
Correspondent
RESPIRONICS CALIFORNIA, INC.
3919 WILLIAM PENN HIGHWAY,
SUITE 200
MURRYSVILLE,  PA  15668 -8550
Correspondent Contact ROBERT M MARSHALL
Regulation Number868.5895
Classification Product Code
CBK  
Date Received03/22/2011
Decision Date 08/19/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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