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510(k) K001896

KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ ECG 110 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS WITH EC by Suzuken Co., Ltd. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2001
Date Received
June 21, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
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)
  • 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)

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