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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
Applicant Contact PENNI PANNELL
Correspondent
Nihon Kohden America, Inc.
2601 Campus Dr.
Irvine,  CA  92612
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
Predetermined Change
Control Plan Authorized		 No
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