DeviceClearance

K100310

Substantially Equivalent

BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS

Applicant
BTL Industries, Inc.
Product code
MWJ
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Austin, TX, US
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.