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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 K914424
Device Name MODEL 6213 REMOTE ALARM
Applicant
Aequitron Medical, Inc.
14800 28th Ave. N.
Plymouth,  MN  55447
Applicant Contact KENNETH B HERLAND
Correspondent
Aequitron Medical, Inc.
14800 28th Ave. N.
Plymouth,  MN  55447
Correspondent Contact KENNETH B HERLAND
Regulation Number868.5895
Classification Product Code
CBK  
Date Received10/03/1991
Decision Date 09/10/1992
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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