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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Breathing Frequency
510(k) Number K884637
Device Name MODEL 9550/9500 RESPIRATION/HEART RATE MONITOR
Applicant
Aequitron Medical, Inc.
14800 28th Ave. N.
Minneapolis,  MN  55447 -4834
Applicant Contact KENNETH B HERLAND
Correspondent
Aequitron Medical, Inc.
14800 28th Ave. N.
Minneapolis,  MN  55447 -4834
Correspondent Contact KENNETH B HERLAND
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received11/07/1988
Decision Date 01/30/1989
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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