Wireless Audio System
FDA 510(k) K173409 · Neocoil, LLC
510(k) numberK173409
Submission
- Device name
- Wireless Audio System
- Applicant
- Neocoil, LLC
Pewaukee, WI, US - Received
- November 1, 2017
- Decision date
- February 16, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Wireless Audio System cleared by the FDA?
Wireless Audio System (K173409) received a 510(k) decision of Substantially Equivalent on February 16, 2018, 107 days after the submission was received.
What is the product code of K173409?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.