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FDA 510(k)

KENZ CARDY302 MAX

K-Number: K101024 · 2011-01-06

ApplicantSuzuken Co., Ltd.
Decision Date2011-01-06
Product CodeMWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KENZ CARDY302 MAX 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 2011-01-06 under 510(k) number K101024. The device is classified under product code MWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KENZ CARDY302 MAX?

KENZ CARDY302 MAX is a medical device that received FDA 510(k) clearance on 2011-01-06. The listed applicant is Suzuken Co., Ltd.. The 510(k) number is K101024.

When did KENZ CARDY302 MAX receive FDA 510(k) clearance?

KENZ CARDY302 MAX received FDA 510(k) clearance on 2011-01-06, under 510(k) number K101024.

Who is the listed applicant for KENZ CARDY302 MAX?

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 CARDY302 MAX?

The FDA product code for KENZ CARDY302 MAX is MWJ.

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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 Cardico1211K092389DISPOSAL ECG ELECTRODES, MODEL EASYRODEK001896KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ ECG 110 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS WITH ECK870443KENZ-CARDICO 1201K862544KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPHK843731KENZ 80Z MARK II

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Related Devices (Code: MWJ)

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.

K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303)Shenzhen Xinyan Medical Technology Co.,ltd.K253529Peerbridge COR MDx (Cor MDx)Peerbridge Health, Inc.K253562medilogFDSchiller AGK253384mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)Seers Technology Co., Ltd.K252839ZywieZ3 Sensor & AdhesiveZywie, Inc.K231424HeartBeam AIMIGo(TM) SystemHeartbeam, 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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