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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 K921454
Device Name FUKUDA DENSHI MODEL HG-301
Original Applicant
FUKUDA DENSHI USA, INC.
7102-a 180th avenue northeast
redmond,  WA  98052
Original Contact robert steurer
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/26/1992
Decision Date 04/01/1994
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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