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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K001742
Device Name RESUSCI INFLATE-A-SHIELD CPR BARRIER
Applicant
Laerdal Medical Corp.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact CYNTHIA J NOLTE
Correspondent
Laerdal Medical Corp.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact CYNTHIA J NOLTE
Regulation Number868.5870
Classification Product Code
CBP  
Date Received06/08/2000
Decision Date 10/06/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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