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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K952880
Device Name MODEL LP-1000 VOLUME VENTILATOR
Applicant
AEQUITRON MEDICAL, INC.
14800 28TH AVE. NORTH
MINNEAPOLIS,  MN  55447
Applicant Contact ROBERT C SAMEC
Correspondent
AEQUITRON MEDICAL, INC.
14800 28TH AVE. NORTH
MINNEAPOLIS,  MN  55447
Correspondent Contact ROBERT C SAMEC
Regulation Number868.5895
Classification Product Code
CBK  
Date Received06/22/1995
Decision Date 06/20/1996
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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