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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 K900730
Device Name ARVEE APNEA MONITOR, MODEL 4800
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 Received02/15/1990
Decision Date 06/14/1990
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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