#505 PORT. VITAL FUNCTIONS NEONATAL MON— 510(k) K820416

Substantially Equivalent

Ge Medical Systems Information Technologies

FDA 510(k) clearance K820416 for #505 PORT. VITAL FUNCTIONS NEONATAL MON, Substantially Equivalent on 1982-03-04. Applicant: Ge Medical Systems Information Technologies.

Clearance details

Applicant: Ge Medical Systems Information Technologies
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1982-02-16
Decision date: 1982-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.