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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 K872631
Device Name INFANT MONITOR, MODEL 2400
Applicant
ARVEE MEDICAL, INC.
730 E. MICHIGAN AVE.
BATTLE CREEK,  MI  49016
Applicant Contact KUMAR KULKARNI
Correspondent
ARVEE MEDICAL, INC.
730 E. MICHIGAN AVE.
BATTLE CREEK,  MI  49016
Correspondent Contact KUMAR KULKARNI
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received07/06/1987
Decision Date 10/26/1987
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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