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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 K932199
Device Name LSPI AUTOMATIC VENTILATOR, MODEL AV3000
Applicant
Life Support Products, Inc.
One Mauchly
Irvine,  CA  92718
Applicant Contact THOMAS FANGROW
Correspondent
Life Support Products, Inc.
One Mauchly
Irvine,  CA  92718
Correspondent Contact THOMAS FANGROW
Regulation Number868.5925
Classification Product Code
BTL  
Date Received05/06/1993
Decision Date 11/24/1993
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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