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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 K992455
Device Name NIHON KOHDEN OGS-2001A POCKETCARE AND ACCESSORIES
Original Applicant
NIHON KOHDEN AMERICA, INC.
2601 campus dr.
irvine,  CA  92612 -1601
Original Contact bonnie bishop
Regulation Number870.2700
Classification Product Code
DQA  
Date Received07/23/1999
Decision Date 01/07/2000
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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