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510(k) K103134

FUKUDA DENSHI by Fukuda Denshi USA, Inc. — Product Code MHX

K103134 is an FDA 510(k) premarket notification submitted by Fukuda Denshi USA, Inc. for the device "FUKUDA DENSHI". The FDA issued a decision of Substantially Equivalent on March 11, 2011. The device falls under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.1025. Fukuda Denshi USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2011
Date Received
October 25, 2010
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)
  • K134046 — FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR (February 12, 2015)
  • K112521 — FUKUDA DENSHI VASERA MODEL VS-1500 (December 21, 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)

Other clearances for product code MHX

  • K254209 — Radius VSM and Accessories (June 4, 2026)
  • K252840 — M12 Telemetry System (May 29, 2026)
  • K260098 — ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A (May 20, 2026)
  • K250349 — Vista CMS (April 24, 2026)
  • K253170 — uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors (April 16, 2026)
  • K252250 — Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasi (April 10, 2026)
  • K252726 — IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX10 (February 6, 2026)
  • K252589 — Corvair Monza (January 9, 2026)
  • K250854 — Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); (December 17, 2025)
  • K251702 — IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4 (November 10, 2025)

FDA data resources