CARESCAPE MONITOR B850— 510(k) K092027

Substantially Equivalent

Ge Medical Systems Information Technologies

FDA 510(k) clearance K092027 for CARESCAPE MONITOR B850, Substantially Equivalent on 2009-08-28. Applicant: Ge Medical Systems Information Technologies.

Clearance details

Applicant: Ge Medical Systems Information Technologies
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2009-07-06
Decision date: 2009-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Needham, MA, 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.