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FDA 510(k)

KENZ-CARDICO 1201

K-Number: K870443 · 1987-07-01

ApplicantSuzuken Co., Ltd.
Decision Date1987-07-01
Product CodeLOS
DecisionSubstantially Equivalent

Device Summary

KENZ-CARDICO 1201 is the device name listed in this FDA 510(k) record. The listed applicant is Suzuken Co., Ltd.. It received FDA 510(k) clearance on 1987-07-01 under 510(k) number K870443. The device is classified under product code LOS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KENZ-CARDICO 1201?

KENZ-CARDICO 1201 is a medical device that received FDA 510(k) clearance on 1987-07-01. The listed applicant is Suzuken Co., Ltd.. The 510(k) number is K870443.

When did KENZ-CARDICO 1201 receive FDA 510(k) clearance?

KENZ-CARDICO 1201 received FDA 510(k) clearance on 1987-07-01, under 510(k) number K870443.

Who is the listed applicant for KENZ-CARDICO 1201?

The FDA 510(k) record lists Suzuken Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KENZ-CARDICO 1201?

The FDA product code for KENZ-CARDICO 1201 is LOS.

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Other records listing Suzuken Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K172068Kenz Cardico1211K101024KENZ CARDY302 MAXK092389DISPOSAL ECG ELECTRODES, MODEL EASYRODEK001896KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ ECG 110 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS WITH ECK862544KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPHK843731KENZ 80Z MARK II

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Related Devices (Code: LOS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K090895EKG-PLUS II SOFTWAREBionet Co., Ltd.K083749CARDIOVIEW32 REVIEW MODULEQrs Diagnostic, LLCK073376PHILIPS ECG ALGORITHMPhilips Medical SystemsK023034CARDIOTOUCH-3000Bionet Company, Ltd.K011328CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPHBionet Company, Ltd.K993616CARDIO-CARD INTERPRETATION SYSTEM INasiff Assoc., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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