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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transducer, gas pressure
510(k) Number K944027
Device Name AG-839PA CO2 MODULE AND ACCESSORIES
Applicant
NIHON KOHDEN AMERICA, INC.
2601 CAMPUS DR.
IRVINE,  CA  92612 -1601
Applicant Contact PENNI PANNELL
Correspondent
NIHON KOHDEN AMERICA, INC.
2601 CAMPUS DR.
IRVINE,  CA  92612 -1601
Correspondent Contact PENNI PANNELL
Regulation Number868.2900
Classification Product Code
BXO  
Date Received08/17/1994
Decision Date 08/31/1994
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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