DeviceClearance

K071085

Substantially Equivalent

E3-80 PORTABLE ECG RECORDER & ANALYZER

Applicant
Micro-Star International Co., Ltd.
Product code
MWJ
Advisory panel
Cardiovascular
Date received
Decision date
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, through . 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.