The following data is part of a premarket notification filed by Passy-muir, Inc. with the FDA for Passy-muir Low-profile Tracheostomy Speaking Valve Pmv 2020 (clear) Jit.
| Device ID | K990905 |
| 510k Number | K990905 |
| Device Name: | PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | PASSY-MUIR, INC. 4521 CAMPUS DR., SUITE 273 Irvine, CA 92612 |
| Contact | Patricia E Passy |
| Correspondent | Patricia E Passy PASSY-MUIR, INC. 4521 CAMPUS DR., SUITE 273 Irvine, CA 92612 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-18 |
| Decision Date | 1999-06-11 |