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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 K871551
Device Name MODEL NUMBER 8200 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 Received04/22/1987
Decision Date 06/05/1987
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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