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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. N.
Plymouth,  MN  55447
Applicant Contact ROBERT C SAMEC
Correspondent
Aequitron Medical, Inc.
14800 28th Ave. N.
Plymouth,  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
Predetermined Change
Control Plan Authorized		 No
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