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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 K903020
Device Name RESPIRATION/HEART RATE MONITOR MODEL 9500/9550
Applicant
AEQUITRON MEDICAL, INC.
14800 28TH AVE. NORTH
MINNEAPOLIS,  MN  55447 -4834
Applicant Contact KENNETH HERLAND
Correspondent
AEQUITRON MEDICAL, INC.
14800 28TH AVE. NORTH
MINNEAPOLIS,  MN  55447 -4834
Correspondent Contact KENNETH HERLAND
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received07/11/1990
Decision Date 04/10/1991
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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