K990905 is an FDA 510(k) clearance for the PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT. This device is classified as a Tube Tracheostomy And Tube Cuff (Class II - Special Controls, product code JOH).
Submitted by Passy-Muir, Inc. (Irvine, US). The FDA issued a Cleared decision on June 11, 1999, 85 days after receiving the submission on March 18, 1999.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5800.
| 510(k) Number | K990905 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 1999 |
| Decision Date | June 11, 1999 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | JOH - Tube Tracheostomy And Tube Cuff |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5800 |