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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 K812045
Device Name INFANT APNEA MONITOR MODEL 100
Applicant
MEDIX MEDICAL ELECTRONICS (U.S.A.), INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MEDIX MEDICAL ELECTRONICS (U.S.A.), INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received07/21/1981
Decision Date 09/24/1981
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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