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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 K961972
Device Name MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR
Applicant
AEQUITRON MEDICAL, INC.
14800 28TH AVE. NORTH
MINNEAPOLIS,  MN  55447
Applicant Contact ROBERT C SAMEC
Correspondent
AEQUITRON MEDICAL, INC.
14800 28TH AVE. NORTH
MINNEAPOLIS,  MN  55447
Correspondent Contact ROBERT C SAMEC
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received05/20/1996
Decision Date 04/18/1997
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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