Coils, Models MCF-B65, MCF-75, MCF-125 and COOL-B65
FDA 510(k) K071821 · Tonica Elektronik A/S
510(k) numberK071821
Submission
- Device name
- Coils, Models MCF-B65, MCF-75, MCF-125 and COOL-B65
- Applicant
- Tonica Elektronik A/S
Farum, DK - Received
- July 3, 2007
- Decision date
- July 27, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Coils, Models MCF-B65, MCF-75, MCF-125 and COOL-B65 cleared by the FDA?
Coils, Models MCF-B65, MCF-75, MCF-125 and COOL-B65 (K071821) received a 510(k) decision of Substantially Equivalent on July 27, 2007, 24 days after the submission was received.
What is the product code of K071821?
The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.