SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR— 510(k) K081365
Substantially EquivalentSt Jude Medical
FDA 510(k) clearance K081365 for SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR, Substantially Equivalent on 2008-08-15. Applicant: St Jude Medical.
Clearance details
- Applicant
- St Jude Medical
- Product code
- Code MXC
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Adverse events under product code MXC
product code MXC- Death
- 4
- Injury
- 758
- Malfunction
- 5,066
- Total
- 5,828
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.