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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Manual (Resuscitator)
510(k) Number K880450
Device Name RESUSCI PATIENT FACE SHIELD
Applicant
LAERDAL MEDICAL CORP.
P.O. BOX 190, ONE LABRIOLA CT.
ARMONK,  NY  10504
Applicant Contact RONALD L WEYHRAUCH
Correspondent
LAERDAL MEDICAL CORP.
P.O. BOX 190, ONE LABRIOLA CT.
ARMONK,  NY  10504
Correspondent Contact RONALD L WEYHRAUCH
Regulation Number868.5915
Classification Product Code
BTM  
Date Received02/02/1988
Decision Date 03/04/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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