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FDA 510(k)

DYNAMIC ECG SYSTEM MODEL TLC5000

K-Number: K101273 · 2011-09-30

ApplicantContec Medical System Co., Ltd.
Decision Date2011-09-30
Product CodeMLO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DYNAMIC ECG SYSTEM MODEL TLC5000 is the device name listed in this FDA 510(k) record. The listed applicant is Contec Medical System Co., Ltd.. It received FDA 510(k) clearance on 2011-09-30 under 510(k) number K101273. The device is classified under product code MLO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNAMIC ECG SYSTEM MODEL TLC5000?

DYNAMIC ECG SYSTEM MODEL TLC5000 is a medical device that received FDA 510(k) clearance on 2011-09-30. The listed applicant is Contec Medical System Co., Ltd.. The 510(k) number is K101273.

When did DYNAMIC ECG SYSTEM MODEL TLC5000 receive FDA 510(k) clearance?

DYNAMIC ECG SYSTEM MODEL TLC5000 received FDA 510(k) clearance on 2011-09-30, under 510(k) number K101273.

Who is the listed applicant for DYNAMIC ECG SYSTEM MODEL TLC5000?

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

What is the FDA product code for DYNAMIC ECG SYSTEM MODEL TLC5000?

The FDA product code for DYNAMIC ECG SYSTEM MODEL TLC5000 is MLO.

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Other records listing Contec Medical System 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.

K180837CONTEC Oxygen ConcentratorK110156AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMETER,K101692PATIENT MONITORK110774ELECTRONIC SPHYGMOMANOMETERK101127PATIENT MONITOR, MODEL PM50K090936SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A

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Related Devices (Code: MLO)

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.

K261580ZBPro Diagnostic (Version 2.0)Zbeats, Inc.K241890Philips Holter Analysis SystemPhilips Medizin Systeme Böblingen GmbHK240794Frontier X PlusFourth Frontier Technologies Pvt, Ltd.K200833RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.K193177CER-SCardiocalmK182030Faros MobileBittium Biosignals , Ltd.

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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