The following data is part of a premarket notification filed by Trudell Medical Int'l with the FDA for Aerochamber Plus Valved Holding Chamber.
| Device ID | K992917 |
| 510k Number | K992917 |
| Device Name: | AEROCHAMBER PLUS VALVED HOLDING CHAMBER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | TRUDELL MEDICAL INT'L 725 THIRD ST. London, Ontario, CA N5v 5g4 |
| Contact | Darryl Fischer |
| Correspondent | Darryl Fischer TRUDELL MEDICAL INT'L 725 THIRD ST. London, Ontario, CA N5v 5g4 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-30 |
| Decision Date | 1999-09-14 |