DELTA T— 510(k) K041076

Substantially Equivalent

Penlon , Ltd.

FDA 510(k) clearance K041076 for DELTA T, Substantially Equivalent on 2004-08-09. Applicant: Penlon , Ltd..

Clearance details

Applicant: Penlon , Ltd.
Product code: Code CAD
Advisory panel: Anesthesiology
Date received: 2004-04-26
Decision date: 2004-08-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Abingdon, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAD

product code CAD

Malfunction: 3,275
Total: 3,275

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.