MOSFET AUTOSENSE, MODEL TN-RD-60— 510(k) K013279

Substantially Equivalent

Thomson & Nielsen Electronics, Ltd.

FDA 510(k) clearance K013279 for MOSFET AUTOSENSE, MODEL TN-RD-60, Substantially Equivalent on 2001-10-18. Applicant: Thomson & Nielsen Electronics, Ltd..

Clearance details

Applicant: Thomson & Nielsen Electronics, Ltd.
Product code: Code IYE
Advisory panel: Radiology
Date received: 2001-10-02
Decision date: 2001-10-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Ottawa, Ontario, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.