Confirm Rx Insertable Cardiac Monitor— 510(k) K192593

Name: FDA 510(k) clearance K192593
Creator: U.S. Food and Drug Administration
Published: 2019-10-18

Substantially Equivalent

Abbott

FDA 510(k) clearance K192593 for Confirm Rx Insertable Cardiac Monitor, Substantially Equivalent on 2019-10-18. Applicant: Abbott. Device class: 2.

Clearance details

Applicant: Abbott
Product code: Code MXC
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2019-09-20
Decision date: 2019-10-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Sylmar, CA, US

Download summary PDF View on FDA.gov ↗

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K202876 — Confirm Rx Insertable Cardiac Monitor2020-12-01
K202888 — Confirm Rx Insertable Cardiac Monitor2020-11-23
K193310 — myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)2020-03-17

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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.