MICRO AMBULATORY ECG RECORDER— 510(k) K131572

Name: FDA 510(k) clearance K131572
Creator: U.S. Food and Drug Administration
Published: 2013-07-22

Substantially Equivalent

Dimetek Digital Medical Technologies, Ltd.

FDA 510(k) clearance K131572 for MICRO AMBULATORY ECG RECORDER, Substantially Equivalent on 2013-07-22. Applicant: Dimetek Digital Medical Technologies, Ltd.. Device class: 2.

Clearance details

Applicant: Dimetek Digital Medical Technologies, Ltd.
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 2013-05-31
Decision date: 2013-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shekou, Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.