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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 K884536
Device Name AL-800PA PULSE OXIMETER MODULE
Applicant
NIHON KOHDEN AMERICA, INC.
17112 ARMSTRONG AVE.
IRVINE,  CA  92714
Applicant Contact MIKE DASHEFSKY
Correspondent
NIHON KOHDEN AMERICA, INC.
17112 ARMSTRONG AVE.
IRVINE,  CA  92714
Correspondent Contact MIKE DASHEFSKY
Regulation Number870.2700
Classification Product Code
DQA  
Date Received10/28/1988
Decision Date 02/06/1989
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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