Wearable Device, Wearable Package— 510(k) K191272

Name: FDA 510(k) clearance K191272
Creator: U.S. Food and Drug Administration
Published: 2019-07-12

Substantially Equivalent

Current Health , Ltd.

FDA 510(k) clearance K191272 for Wearable Device, Wearable Package, Substantially Equivalent on 2019-07-12. Applicant: Current Health , Ltd.. Device class: 2.

Clearance details

Applicant: Current Health , Ltd.
Product code: Code MSX
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2019-05-13
Decision date: 2019-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edinburgh, GB

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MSX

product code MSX

Death: 59
Total: 59

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.