LITEGUARD 9— 510(k) K851924

Substantially Equivalent

Temtech , Ltd.

FDA 510(k) clearance K851924 for LITEGUARD 9, Substantially Equivalent on 1985-08-06. Applicant: Temtech , Ltd..

Clearance details

Applicant: Temtech , Ltd.
Product code: Code LDD
Advisory panel: Cardiovascular
Date received: 1985-05-02
Decision date: 1985-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bangot,Co. Down Bt192qy, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code LDD

product code LDD

Death: 38
Malfunction: 522
Total: 560

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.