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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Attachment, Breathing, Positive End Expiratory Pressure
510(k) Number K013884
Device Name BOUSSIGNAC C.P.A.P. DEVICE
Applicant
VYGON S A
45900 PARSIPPANY COURT
TEMECULA,  CA  92592
Applicant Contact LAETITIA BERNARD
Correspondent
VYGON S A
45900 PARSIPPANY COURT
TEMECULA,  CA  92592
Correspondent Contact LAETITIA BERNARD
Regulation Number868.5965
Classification Product Code
BYE  
Date Received11/23/2001
Decision Date 01/21/2003
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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