| K-number | K231604 |
| Device name | Instrument Case |
| Applicant | Cochlear Americas |
| Product code | KCT |
| Device class | Class II |
| Decision date | Aug 24, 2023 |
| Decision | Substantially Equivalent |
| Regulation | 880.6850 |
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