The following data is part of a premarket notification filed by Mriaudio, Inc. with the FDA for Mriaudio Prem System With Mriview.
| Device ID | K193102 |
| 510k Number | K193102 |
| Device Name: | MRIaudio PREM System With MRIview |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MRIaudio, Inc. 5909 Sea Lion Place, Suite F Carlsbad, CA 92010 |
| Contact | Joseph Caruso |
| Correspondent | Joseph Caruso MRIaudio, Inc. 5909 Sea Lion Place, Suite F Carlsbad, CA 92010 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-08 |
| Decision Date | 2020-01-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B66935011 | K193102 | 000 |
| B66935001 | K193102 | 000 |
| B66930001 | K193102 | 000 |