Patient Cables and Leadwires , Disposable ECG Leadwires— 510(k) K182327

Name: FDA 510(k) clearance K182327
Creator: U.S. Food and Drug Administration
Published: 2019-01-30

Substantially Equivalent

Orantech, Inc.

FDA 510(k) clearance K182327 for Patient Cables and Leadwires , Disposable ECG Leadwires, Substantially Equivalent on 2019-01-30. Applicant: Orantech, Inc.. Device class: 2.

Clearance details

Applicant: Orantech, Inc.
Product code: Product code DSA
Device class: Class 2
Regulation: 21 CFR 870.2900
Advisory panel: Cardiovascular
Date received: 2018-08-27
Decision date: 2019-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DSA

product code DSA

Death: 2
Total: 2

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.