DeviceClearance

K152995

Substantially Equivalent

BioMonitor 2-AF, BioMonitor 2-S

Applicant
Biotronik, Inc.
Product code
MXD
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lake Oswego, OR, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code MXD

product code MXD
Injury
1,880
Malfunction
9,487
Total
11,367

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.