LITTON DATAMEDIX BLOOD PRESSURE MONITOR NI— 510(k) K853599

Substantially Equivalent

Litton Datamedix

FDA 510(k) clearance K853599 for LITTON DATAMEDIX BLOOD PRESSURE MONITOR NI, Substantially Equivalent on 1986-03-21. Applicant: Litton Datamedix.

Clearance details

Applicant: Litton Datamedix
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1985-08-27
Decision date: 1986-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sharon, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

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.