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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
Applicant
NIHON KOHDEN AMERICA, INC.
2601 CAMPUS DR.
IRVINE,  CA  92612 -1601
Applicant Contact GARY REASONER
Correspondent
NIHON KOHDEN AMERICA, INC.
2601 CAMPUS DR.
IRVINE,  CA  92612 -1601
Correspondent Contact GARY REASONER
Regulation Number870.2700
Classification Product Code
DQA  
Date Received11/14/1997
Decision Date 06/08/1998
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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