The following data is part of a premarket notification filed by Neocoil, Llc with the FDA for Wireless Audio System.
| Device ID | K173409 |
| 510k Number | K173409 |
| Device Name: | Wireless Audio System |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | NeoCoil, LLC N27 W23910A Paul Rd. Pewaukee, WI 53072 |
| Contact | Michael Leigh |
| Correspondent | Michael Leigh NeoCoil, LLC N27 W23910A Paul Rd. Pewaukee, WI 53072 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-01 |
| Decision Date | 2018-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856181003800 | K173409 | 000 |
| 00856181003794 | K173409 | 000 |
| 00856181003787 | K173409 | 000 |
| 00856181003770 | K173409 | 000 |
| 00856181003763 | K173409 | 000 |
| 00856181003756 | K173409 | 000 |