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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 K974292
Device Name NIHON KOHDEN TL-101T, TL-120T AND TL-121T SPO2 PROBES AND ACCESSORIES
Original Applicant
NIHON KOHDEN AMERICA, INC.
2601 campus dr.
irvine,  CA  92612 1601
Original Contact gary reasoner
Regulation Number870.2700
Classification Product Code
DQA  
Date Received11/14/1997
Decision Date 06/08/1998
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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