DYNAMIC ECG SYSTEM MODEL TLC5000— 510(k) K101273

Name: FDA 510(k) clearance K101273
Creator: U.S. Food and Drug Administration
Published: 2011-09-30

Substantially Equivalent

Contec Medical System Co., Ltd.

FDA 510(k) clearance K101273 for DYNAMIC ECG SYSTEM MODEL TLC5000, Substantially Equivalent on 2011-09-30. Applicant: Contec Medical System Co., Ltd.. Device class: 2.

Clearance details

Applicant: Contec Medical System Co., Ltd.
Product code: Code MLO
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2010-05-06
Decision date: 2011-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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