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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 K853084
Device Name MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM)
Applicant
AEQUITRON MEDICAL, INC.
14800 28TH AVE. NORTH
MINNEAPOLIS,  MN  55447 -4834
Applicant Contact ROBERT C SAMEC
Correspondent
AEQUITRON MEDICAL, INC.
14800 28TH AVE. NORTH
MINNEAPOLIS,  MN  55447 -4834
Correspondent Contact ROBERT C SAMEC
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received07/23/1985
Decision Date 08/02/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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