Creavo Vitalscan Magnetocardiograph— 510(k) K170154

Name: FDA 510(k) clearance K170154
Creator: U.S. Food and Drug Administration
Published: 2017-10-12

Substantially Equivalent

Creavo Medical Technologies, Ltd.

FDA 510(k) clearance K170154 for Creavo Vitalscan Magnetocardiograph, Substantially Equivalent on 2017-10-12. Applicant: Creavo Medical Technologies, Ltd.. Device class: 2.

Clearance details

Applicant: Creavo Medical Technologies, Ltd.
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 2017-01-18
Decision date: 2017-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Coventry, GB

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.