The following data is part of a premarket notification filed by Innovere Medical Inc. with the FDA for Innovision Audio.
| Device ID | K193218 |
| 510k Number | K193218 |
| Device Name: | Innovision Audio |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Innovere Medical Inc. 6-250 Shields Court Markham, CA L3r 9w7 |
| Contact | Lynsie Thomason |
| Correspondent | Lynsie Thomason Innovere Medical Inc. 6-250 Shields Court Markham, CA L3r 9w7 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-21 |
| Decision Date | 2020-04-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628176432212 | K193218 | 000 |