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FDA 510(k)

Portable ECG Monitor

K-Number: K170954 · 2017-05-30

ApplicantContec Medical Systems Co.,Ltd
Decision Date2017-05-30
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Portable ECG Monitor is a medical device manufactured by Contec Medical Systems Co.,Ltd. It received FDA 510(k) clearance on 2017-05-30 under approval number K170954. 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 Portable ECG Monitor?

Portable ECG Monitor is a medical device that received FDA 510(k) clearance on 2017-05-30. It is manufactured by Contec Medical Systems Co.,Ltd. The 510(k) number is K170954.

When was Portable ECG Monitor approved by the FDA?

Portable ECG Monitor received FDA 510(k) clearance on 2017-05-30, under approval number K170954.

What company makes Portable ECG Monitor?

Portable ECG Monitor is manufactured by Contec Medical Systems Co.,Ltd.

What is the FDA product code for Portable ECG Monitor?

The FDA product code for Portable ECG Monitor is DPS.

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Other Devices by Contec Medical Systems Co.,Ltd

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Related Devices (Code: DPS)

K160746CARDIOLINE touchECGCardioline S.P.A K160840ECG100+, ECG200+Cardioline S.P.A K152135Quantitative Electrocardiographic Detector (QED 2000)Acme Portable Machines, Inc. K161302PC ECGEdan Instruments, Inc. K152863Portable ECG MonitorContec Medical Systems Co.,Ltd K152043Diagnostic Station DS20Schiller AG

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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