DeviceClearance

K133014

Substantially Equivalent

DMS 300-2W HOLTER ECG RECORDER

Applicant
Diagnostic Monitoring Software
Product code
MWJ
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Stateline, NV, 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.