MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, MODEL TN-RD-70-W— 510(k) K041557

Name: FDA 510(k) clearance K041557
Creator: U.S. Food and Drug Administration
Published: 2004-06-25

Substantially Equivalent

Thomson & Nielsen Electronics, Ltd.

FDA 510(k) clearance K041557 for MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, MODEL TN-RD-70-W, Substantially Equivalent on 2004-06-25. Applicant: Thomson & Nielsen Electronics, Ltd.. Device class: 2.

Clearance details

Applicant: Thomson & Nielsen Electronics, Ltd.
Product code: Code IYE
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2004-06-10
Decision date: 2004-06-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Ottawa, Ontario, CA

Download summary PDF View on FDA.gov ↗

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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.