SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL— 510(k) K091206

Name: FDA 510(k) clearance K091206
Creator: U.S. Food and Drug Administration
Published: 2009-05-18

Substantially Equivalent

Transoma Medical

FDA 510(k) clearance K091206 for SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL, Substantially Equivalent on 2009-05-18. Applicant: Transoma Medical. Device class: 2.

Clearance details

Applicant: Transoma Medical
Product code: Code MXC
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2009-04-24
Decision date: 2009-05-18
Decision: Substantially Equivalent
Clearance type: Special
Location: St. Paul, MN, 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.