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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name oximeter
510(k) Number K013273
Device Name FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE
Original Applicant
FUKUDA DENSHI USA, INC.
17725 n.e. 65th st., bldg. c
redmond,  WA  98052 -4911
Original Contact larry walker
Regulation Number870.2700
Classification Product Code
DQA  
Date Received10/01/2001
Decision Date 12/20/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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