TELEPRESS III BLOOD PRESSURE MONITOR, MODEL TPIII— 510(k) K011058

Substantially Equivalent

Meridian Medical Technologies , Ltd.

FDA 510(k) clearance K011058 for TELEPRESS III BLOOD PRESSURE MONITOR, MODEL TPIII, Substantially Equivalent on 2001-10-23. Applicant: Meridian Medical Technologies , Ltd..

Clearance details

Applicant: Meridian Medical Technologies , Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2001-04-06
Decision date: 2001-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Belfast, IE

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.