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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 K945464
Device Name FUKUDA DENSHI MODE HG-302 PULSE OXIMETER MODULE
Original Applicant
FUKUDA DENSHI USA, INC.
7102-a 180th avenue northeast
redmond,  WA  98052
Original Contact david j geraghty
Regulation Number870.2700
Classification Product Code
DQA  
Date Received11/07/1994
Decision Date 02/01/1995
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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