SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR— 510(k) K081365

Name: FDA 510(k) clearance K081365
Creator: U.S. Food and Drug Administration
Published: 2008-08-15

Substantially Equivalent

St 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. Device class: 2.

Clearance details

Applicant: St Jude Medical
Product code: Code MXC
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2008-05-15
Decision date: 2008-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MXC

product code MXC

Death: 4
Injury: 758
Malfunction: 5,066
Total: 5,828

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.