COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65— 510(k) K071821

Substantially Equivalent

Tonica Elektronik A/S

FDA 510(k) clearance K071821 for COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65, Substantially Equivalent on 2007-07-27. Applicant: Tonica Elektronik A/S.

Clearance details

Applicant: Tonica Elektronik A/S
Product code: Code GWF
Advisory panel: Neurology
Date received: 2007-07-03
Decision date: 2007-07-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Farum, DK

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Adverse events under product code GWF

product code GWF

Malfunction: 2,364
Other: 4
Total: 2,368

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.