SOLAR 9500 INFORMATION MONITOR— 510(k) K990068

Substantially Equivalent

General Electric Medical Systems Information Techn

FDA 510(k) clearance K990068 for SOLAR 9500 INFORMATION MONITOR, Substantially Equivalent on 1999-07-14. Applicant: General Electric Medical Systems Information Techn.

Clearance details

Applicant: General Electric Medical Systems Information Techn
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 1999-01-08
Decision date: 1999-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
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.