K190073

Substantially Equivalent

Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub

Applicant: Current Health , Ltd.
Product code: MSX
Advisory panel: Cardiovascular
Date received: 2019-01-16
Decision date: 2019-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edinburgh, GB

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.