| K-number | K851016 |
| Device name | PASSY-MUIR TRACH VALVE |
| Applicant | Passy & Passy, Inc. |
| Product code | BTO |
| Device class | Class II |
| Decision date | Jun 7, 1985 |
| Decision | Substantially Equivalent |
| Regulation | 868.5800 |
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