DeviceClearance

K112601

Substantially Equivalent

INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER

Applicant
Intricon Datrix Corporation
Product code
MWJ
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Appollo Beach, FL, 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.