| K-number | K921979 |
| Device name | ROOT ZX |
| Applicant | J. Morita USA, Inc. |
| Product code | LQY |
| Device class | Class U |
| Decision date | May 27, 1993 |
| Decision | Substantially Equivalent |
| Regulation | — |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov