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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 K941870
Device Name LSPI AUTOMATIC VENTILATOR, MODEL AV2000-100
Applicant
Life Support Products, Inc.
1720 Sublette Ave.
Saint Louis,  MO  63110
Applicant Contact VERNON TRIMBLE
Correspondent
Life Support Products, Inc.
1720 Sublette Ave.
Saint Louis,  MO  63110
Correspondent Contact VERNON TRIMBLE
Regulation Number868.5925
Classification Product Code
BTL  
Date Received04/18/1994
Decision Date 01/09/1995
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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