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510(k) K870443

KENZ-CARDICO 1201 by Suzuken Co., Ltd. — Product Code LOS

K870443 is an FDA 510(k) premarket notification submitted by Suzuken Co., Ltd. for the device "KENZ-CARDICO 1201". The FDA issued a decision of Substantially Equivalent on Jul 1, 1987. Suzuken Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 1, 1987
Date Received
Feb 3, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Suzuken Co., Ltd.

  • K172068 — Kenz Cardico1211 (Jun 1, 2018)
  • K101024 — KENZ CARDY302 MAX (Jan 6, 2011)
  • K092389 — DISPOSAL ECG ELECTRODES, MODEL EASYRODE (Oct 13, 2009)
  • K001896 — KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ ECG 110 SINGLE CHA (Jan 8, 2001)
  • K862544 — KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH (Aug 6, 1986)
  • K843731 — KENZ 80Z MARK II (Jul 11, 1985)
  • K822968 — ELECTROCARDIOGRAPH INTERPRETER (Dec 15, 1982)
  • K820854 — KENZ-45M (Jun 1, 1982)
  • K820991 — KENZ-GELECT GEL PAD (Apr 26, 1982)
  • K812263 — KENZ-GELECT (Nov 2, 1981)

Other clearances for product code LOS

  • K090895 — EKG-PLUS II SOFTWARE (Aug 26, 2009)
  • K083749 — CARDIOVIEW32 REVIEW MODULE (Mar 10, 2009)
  • K073376 — PHILIPS ECG ALGORITHM (Apr 11, 2008)
  • K023034 — CARDIOTOUCH-3000 (Nov 14, 2002)
  • K011328 — CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH (Nov 21, 2001)
  • K993616 — CARDIO-CARD INTERPRETATION SYSTEM I (Apr 10, 2000)
  • K984465 — OXYCONALPHA WITH OPTION ECG (Oct 27, 1999)
  • K991014 — CASE 8000 EXERCISE TESTING SYSTEM (Oct 20, 1999)
  • K991735 — MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 (Aug 19, 1999)
  • K990031 — NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES (Apr 16, 1999)

FDA data resources