Home / 510(k) Clearances / K101024

510(k) K101024

KENZ CARDY302 MAX by Suzuken Co., Ltd. — Product Code MWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2011
Date Received
April 13, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph, Ambulatory (Without Analysis)
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

Other clearances by Suzuken Co., Ltd.

  • K172068 — Kenz Cardico1211 (June 1, 2018)
  • K092389 — DISPOSAL ECG ELECTRODES, MODEL EASYRODE (October 13, 2009)
  • K001896 — KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ ECG 110 SINGLE CHA (January 8, 2001)
  • K870443 — KENZ-CARDICO 1201 (July 1, 1987)
  • K862544 — KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH (August 6, 1986)
  • K843731 — KENZ 80Z MARK II (July 11, 1985)
  • K822968 — ELECTROCARDIOGRAPH INTERPRETER (December 15, 1982)
  • K820854 — KENZ-45M (June 1, 1982)
  • K820991 — KENZ-GELECT GEL PAD (April 26, 1982)
  • K812263 — KENZ-GELECT (November 2, 1981)

Other clearances for product code MWJ

  • K231424 — HeartBeam AIMIGo(TM) System (December 13, 2024)
  • K233864 — ASSURE Wearable ECG (May 7, 2024)
  • K212317 — Eclipse MINI Model 98900 (November 7, 2022)
  • K222017 — Biotres (July 28, 2022)
  • K210758 — Q Patch (June 2, 2022)
  • K211709 — Biotres (January 19, 2022)
  • K211651 — Eclipse PRO (November 22, 2021)
  • K173156 — Integrated CardioRespiratory System (June 8, 2018)
  • K161062 — NR Recorder (June 13, 2016)
  • K152626 — H3+ Holter Recorder (February 26, 2016)