CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201— 510(k) K213234

Substantially Equivalent

Ge Medical Systems Information Technologies, Inc.

FDA 510(k) clearance K213234 for CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201, Substantially Equivalent on 2022-04-12. Applicant: Ge Medical Systems Information Technologies, Inc..

Clearance details

Applicant: Ge Medical Systems Information Technologies, Inc.
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2021-09-30
Decision date: 2022-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wauwatosa, 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.