SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT— 510(k) K083828

Name: FDA 510(k) clearance K083828
Creator: U.S. Food and Drug Administration
Published: 2009-02-11

Substantially Equivalent

Transoma

FDA 510(k) clearance K083828 for SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT, Substantially Equivalent on 2009-02-11. Applicant: Transoma. Device class: 2.

Clearance details

Applicant: Transoma
Product code: Product code MXC
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2008-12-23
Decision date: 2009-02-11
Decision: Substantially Equivalent
Clearance type: Special
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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K193310 — myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)2020-03-17

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.