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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 K073410
Device Name SAVE RESUSCITATOR
Applicant
Artivent Corporation
3722 Ave. Sausalito
Irvine,  CA  92606
Applicant Contact GRACE HOLLAND
Correspondent
Artivent Corporation
3722 Ave. Sausalito
Irvine,  CA  92606
Correspondent Contact GRACE HOLLAND
Regulation Number868.5915
Classification Product Code
BTM  
Date Received12/04/2007
Decision Date 09/12/2008
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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