The following data is part of a premarket notification filed by Resoundant Inc with the FDA for Resoundant Acoustic Driver System.
| Device ID | K201389 |
| 510k Number | K201389 |
| Device Name: | Resoundant Acoustic Driver System |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Resoundant Inc 421 First Ave SW Suite 204W Rochester, MN 55902 |
| Contact | John Hartigan |
| Correspondent | John Hartigan Resoundant Inc 421 First Ave SW Suite 204W Rochester, MN 55902 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-27 |
| Decision Date | 2020-07-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850011790106 | K201389 | 000 |
| 00850011790052 | K201389 | 000 |
| 00850011790045 | K201389 | 000 |