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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, gas, carbon-dioxide, gaseous-phase
510(k) Number K894691
Device Name MODEL AO-800PA CO2 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 Number868.1400
Classification Product Code
CCK  
Date Received07/24/1989
Decision Date 12/22/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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