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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K984254
Device Name INFANT FLOW NCPAP MASKS
Applicant
Sensor Medics Corp.
22705 Savi Ranch Pkwy.
Yorba Linda,  CA  92887
Applicant Contact PAUL L KITTINGER
Correspondent
Sensor Medics Corp.
22705 Savi Ranch Pkwy.
Yorba Linda,  CA  92887
Correspondent Contact PAUL L KITTINGER
Regulation Number868.5905
Classification Product Code
BZD  
Date Received11/27/1998
Decision Date 02/24/1999
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
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