CONTEC ELECTROCARDIOGRAPH— 510(k) K131900

Clearance details

Applicant

Contec Medical System Co., Ltd.

Product code

Code DPS

Device class

Class 2

Regulation

21 CFR 870.2340

Advisory panel

Cardiovascular

Date received

2013-06-25

Decision date

2014-03-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Shanghai, CN

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Death

7

Total

7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →