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510(k) K134046

FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR by Fukuda Denshi USA, Inc. — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2015
Date Received
December 31, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Fukuda Denshi USA, Inc.

  • K173226 — CardiMax Electrocardiograph (April 16, 2018)
  • K150030 — Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor (March 16, 2015)
  • K112521 — FUKUDA DENSHI VASERA MODEL VS-1500 (December 21, 2011)
  • K103134 — FUKUDA DENSHI (March 11, 2011)
  • K083697 — FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//700 (March 19, 2009)
  • K082656 — MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT (September 30, 2008)
  • K081891 — FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR (August 29, 2008)
  • K050363 — FUKUDA DENSHI MODEL UF-850XTD (February 17, 2005)
  • K033711 — FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM (June 3, 2004)
  • K040246 — FUKUDA DENSHI DYNASCOPE MODEL DS-7141 PORTABLE PATIENT MONITOR (May 26, 2004)

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