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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, Non-Life-Supporting
510(k) Number K111378
Device Name OXIMETRY INTERFACE KIT
Applicant
PHILIPS RESPIRONICS, INC
1740 GOLDEN MILE HIGHWAY
MONROEVILLE,  PA  15146
Applicant Contact ELAINE LARKIN
Correspondent
PHILIPS RESPIRONICS, INC
1740 GOLDEN MILE HIGHWAY
MONROEVILLE,  PA  15146
Correspondent Contact ELAINE LARKIN
Regulation Number868.5895
Classification Product Code
MNS  
Date Received05/17/2011
Decision Date 10/04/2011
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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