TECOTHERM NEO (T NEO)— 510(k) K140078

Substantially Equivalent

Inspiration Healthcare, Ltd.

FDA 510(k) clearance K140078 for TECOTHERM NEO (T NEO), Substantially Equivalent on 2014-11-14. Applicant: Inspiration Healthcare, Ltd..

Clearance details

Applicant: Inspiration Healthcare, Ltd.
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 2014-01-13
Decision date: 2014-11-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Earl Shilton, Leicester, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWJ

product code DWJ

Death: 7
Injury: 679
Malfunction: 17,477
Total: 18,163

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.