The following data is part of a premarket notification filed by Promedic, Inc. with the FDA for Revjet Turbo.
| Device ID | K060842 |
| 510k Number | K060842 |
| Device Name: | REVJET TURBO |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | PROMEDIC, INC. 6329 WEST WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden PROMEDIC, INC. 6329 WEST WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-28 |
| Decision Date | 2006-06-21 |