Wireless Audio System— 510(k) K173409
Substantially EquivalentNeocoil, LLC
FDA 510(k) clearance K173409 for Wireless Audio System, Substantially Equivalent on 2018-02-16. Applicant: Neocoil, LLC. Device class: 2.
Clearance details
- Applicant
- Neocoil, LLC
- Product code
- Code LNH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pewaukee, WI, US
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Adverse events under product code LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
Source: openFDA MAUDE database, through . 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.