CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES— 510(k) K200494

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K200494 for CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES, Substantially Equivalent on 2020-03-29. Applicant: GE Healthcare.

Clearance details

Applicant: GE Healthcare
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2020-02-28
Decision date: 2020-03-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

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.