TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM— 510(k) K121141

Substantially Equivalent

Tensys Medical Systems, Inc.

FDA 510(k) clearance K121141 for TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM, Substantially Equivalent on 2012-05-15. Applicant: Tensys Medical Systems, Inc..

Clearance details

Applicant: Tensys Medical Systems, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2012-04-16
Decision date: 2012-05-15
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, 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.