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FDA 510(k)

Portable ECG Monitor

K-Number: K152863 · 2016-06-22

ApplicantContec Medical Systems Co.,Ltd
Decision Date2016-06-22
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Portable ECG Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Contec Medical Systems Co.,Ltd. It received FDA 510(k) clearance on 2016-06-22 under 510(k) number K152863. 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 2016-06-22. The listed applicant is Contec Medical Systems Co.,Ltd. The 510(k) number is K152863.

When did Portable ECG Monitor receive FDA 510(k) clearance?

Portable ECG Monitor received FDA 510(k) clearance on 2016-06-22, under 510(k) number K152863.

Who is the listed applicant for Portable ECG Monitor?

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

What is the FDA product code for Portable ECG Monitor?

The FDA product code for Portable ECG Monitor is DPS.

Related Clinical Trials

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.

NCT06589700B2AD-Risk AFDAS Evolution of Burden of AFRECRUITING

Other records listing Contec Medical Systems 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.

K232893Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)K232895B-Ultrasound Diagnostic SystemK232908Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C)K220245Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)K202757CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure MonitorK201980Infrared Thermometer

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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.

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 CommercialK243252ZBPro DiagnosticZbeats, 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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