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FDA 510(k)

KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH

K-Number: K862544 · 1986-08-06

ApplicantSuzuken Co., Ltd.
Decision Date1986-08-06
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH 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 1986-08-06 under 510(k) number K862544. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH?

KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH is a medical device that received FDA 510(k) clearance on 1986-08-06. The listed applicant is Suzuken Co., Ltd.. The 510(k) number is K862544.

When did KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH receive FDA 510(k) clearance?

KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH received FDA 510(k) clearance on 1986-08-06, under 510(k) number K862544.

Who is the listed applicant for KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH?

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-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH?

The FDA product code for KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH is DPS.

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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 ECK870443KENZ-CARDICO 1201K843731KENZ 80Z MARK II

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Related Devices (Code: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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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