The following data is part of a premarket notification filed by Trudell Medical Int'l with the FDA for Aerotrach Plus Valved Holding Chamber (vhc).
| Device ID | K001137 |
| 510k Number | K001137 |
| Device Name: | AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC) |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | TRUDELL MEDICAL INT'L 725 THIRD ST. London, Ontario, CA N5v 5g4 |
| Contact | Tom Holbrook |
| Correspondent | Tom Holbrook 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 | 2000-04-10 |
| Decision Date | 2000-07-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 62860101505022 | K001137 | 000 |
| 00762860015050 | K001137 | 000 |