E3-80 PORTABLE ECG RECORDER & ANALYZER— 510(k) K071085

Substantially Equivalent

Micro-Star International Co., Ltd.

FDA 510(k) clearance K071085 for E3-80 PORTABLE ECG RECORDER & ANALYZER, Substantially Equivalent on 2007-10-03. Applicant: Micro-Star International Co., Ltd..

Clearance details

Applicant: Micro-Star International Co., Ltd.
Product code: Code MWJ
Advisory panel: Cardiovascular
Date received: 2007-04-17
Decision date: 2007-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jung-He City, Taipei Hsien, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWJ

product code MWJ

Other: 1
Total: 1

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.