INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER— 510(k) K112601

Name: FDA 510(k) clearance K112601
Creator: U.S. Food and Drug Administration
Published: 2011-11-09

Substantially Equivalent

Intricon Datrix Corporation

FDA 510(k) clearance K112601 for INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER, Substantially Equivalent on 2011-11-09. Applicant: Intricon Datrix Corporation. Device class: 2.

Clearance details

Applicant: Intricon Datrix Corporation
Product code: Code MWJ
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2011-09-07
Decision date: 2011-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Appollo Beach, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MWJ

product code MWJ

Other: 1
Total: 1

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.