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510(k) Clearances
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510(k) K870443
KENZ-CARDICO 1201 by
Suzuken Co., Ltd.
— Product Code
LOS
Clearance Details
Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1987
Date Received
February 3, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No
Other clearances by Suzuken Co., Ltd.
K172068
— Kenz Cardico1211 (June 1, 2018)
K101024
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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)
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 LOS
K090895
— EKG-PLUS II SOFTWARE (August 26, 2009)
K083749
— CARDIOVIEW32 REVIEW MODULE (March 10, 2009)
K073376
— PHILIPS ECG ALGORITHM (April 11, 2008)
K023034
— CARDIOTOUCH-3000 (November 14, 2002)
K011328
— CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH (November 21, 2001)
K993616
— CARDIO-CARD INTERPRETATION SYSTEM I (April 10, 2000)
K984465
— OXYCONALPHA WITH OPTION ECG (October 27, 1999)
K991014
— CASE 8000 EXERCISE TESTING SYSTEM (October 20, 1999)
K991735
— MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 (August 19, 1999)
K990031
— NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES (April 16, 1999)