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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 K950044
Device Name FUKUDA DENSHI MODEL HC-300 END TIDAL CO2 MODULE
Applicant
Fukuda Denshi USA, Inc.
7102-A 180th Ave. Northeast
Redmond,  WA  98052
Applicant Contact DAVID J GERAGHTY
Correspondent
Fukuda Denshi USA, Inc.
7102-A 180th Ave. Northeast
Redmond,  WA  98052
Correspondent Contact DAVID J GERAGHTY
Regulation Number868.1400
Classification Product Code
CCK  
Date Received01/05/1995
Decision Date 09/15/1995
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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