Carescape One— 510(k) K190008

Name: FDA 510(k) clearance K190008
Creator: U.S. Food and Drug Administration
Published: 2019-12-20

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K190008 for Carescape One, Substantially Equivalent on 2019-12-20. Applicant: GE Healthcare. Device class: 2.

Clearance details

Applicant: GE Healthcare
Product code: Code MHX
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 2019-01-02
Decision date: 2019-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MHX

product code MHX

Death: 580
Injury: 2,441
Malfunction: 12,655
Other: 3
Total: 15,679

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.