The following data is part of a premarket notification filed by Trudell Medical Intl. with the FDA for Aerochamber Mini Ventilation Chamber.
| Device ID | K090065 |
| 510k Number | K090065 |
| Device Name: | AEROCHAMBER MINI VENTILATION CHAMBER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | TRUDELL MEDICAL INTL. 725 THIRD ST. London, Ontario, CA N5v 5g4 |
| Contact | Darryl Fischer |
| Correspondent | Darryl Fischer TRUDELL MEDICAL INTL. 725 THIRD ST. London, Ontario, CA N5v 5g4 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-09 |
| Decision Date | 2009-04-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 62860875010029 | K090065 | 000 |
| 00762860875012 | K090065 | 000 |