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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, powered (resuscitator)
510(k) Number K874656
Device Name AUTOMATIC VENTILATOR AV2000
Applicant
LIFE SUPPORT PRODUCTS, INC.
ONE MAUCHLY
IRVINE,  CA  92718
Applicant Contact TOM FANGROW
Correspondent
LIFE SUPPORT PRODUCTS, INC.
ONE MAUCHLY
IRVINE,  CA  92718
Correspondent Contact TOM FANGROW
Regulation Number868.5925
Classification Product Code
BTL  
Date Received11/19/1987
Decision Date 01/19/1988
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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