The following data is part of a premarket notification filed by Trudell Medical Intl. with the FDA for Aerochamber Max Valved Holding Chamber.
| Device ID | K032972 |
| 510k Number | K032972 |
| Device Name: | AEROCHAMBER MAX VALVED HOLDING CHAMBER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | TRUDELL MEDICAL INTL. 725 THIRD ST. London, Ontario, CA N5v 5g4 |
| Contact | Tom Holbrook |
| Correspondent | Tom Holbrook TRUDELL MEDICAL INTL. 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 | 2003-09-24 |
| Decision Date | 2004-01-14 |