Wearable Device; Cradle; Small Strap, Medium Strap, Large Strap; Multiple Device Charger; Hospital Starter Package— 510(k) K182543

Name: FDA 510(k) clearance K182543
Creator: U.S. Food and Drug Administration
Published: 2018-11-14

Substantially Equivalent

Snap40, Ltd.

FDA 510(k) clearance K182543 for Wearable Device; Cradle; Small Strap, Medium Strap, Large Strap; Multiple Device Charger; Hospital Starter Package, Substantially Equivalent on 2018-11-14. Applicant: Snap40, Ltd.. Device class: 2.

Clearance details

Device name as filed: Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package
Applicant: Snap40, Ltd.
Product code: Code MSX
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2018-09-17
Decision date: 2018-11-14
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.