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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 K980979
Device Name FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE
Applicant
FUKUDA DENSHI USA, INC.
17725 N.E. 65TH ST., BLDG. C
REDMOND,  WA  98052 -4911
Applicant Contact DAVID J GERAGHTY
Correspondent
FUKUDA DENSHI USA, INC.
17725 N.E. 65TH ST., BLDG. C
REDMOND,  WA  98052 -4911
Correspondent Contact DAVID J GERAGHTY
Regulation Number868.1400
Classification Product Code
CCK  
Date Received03/17/1998
Decision Date 06/12/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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