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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
SENSORMEDICS CORP.
22705 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887 -4645
Applicant Contact PAUL L KITTINGER
Correspondent
SENSORMEDICS CORP.
22705 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887 -4645
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
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