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510(k) K980979

FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE by Fukuda Denshi USA, Inc. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1998
Date Received
March 17, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1400
Review Panel
AN
Submission Type

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  • K050363 — FUKUDA DENSHI MODEL UF-850XTD (February 17, 2005)
  • K033711 — FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM (June 3, 2004)

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