The following data is part of a premarket notification filed by Trudell Medical Intl. with the FDA for Aerochamber Plus Anti-static Valved Holding Chamber With Flow-vu Inspiratory Flow Indicator.
| Device ID | K070674 |
| 510k Number | K070674 |
| Device Name: | AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR |
| Classification | Holding Chambers, Direct Patient Interface |
| Applicant | TRUDELL MEDICAL INTL. 725 THIRD ST. London, Ontario, CA N5v 5g4 |
| Contact | John Straatman |
| Correspondent | John Straatman TRUDELL MEDICAL INTL. 725 THIRD ST. London, Ontario, CA N5v 5g4 |
| Product Code | NVP |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-12 |
| Decision Date | 2007-04-11 |