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510(k) K843731

KENZ 80Z MARK II by Suzuken Co., Ltd. — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1985
Date Received
September 24, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector And Alarm, Arrhythmia
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Suzuken Co., Ltd.

  • K172068 — Kenz Cardico1211 (June 1, 2018)
  • K101024 — KENZ CARDY302 MAX (January 6, 2011)
  • 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)
  • 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)

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