K181649 is an FDA 510(k) clearance for the AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC). This device is classified as a Holding Chambers, Direct Patient Interface (Class II - Special Controls, product code NVP).
Submitted by Trudell Medical International (London, CA). The FDA issued a Cleared decision on January 11, 2019, 203 days after receiving the submission on June 22, 2018.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630. Holding Chambers Are Devices That Are Used With Nebulizers And Metered Dose Inhalers And Are Comprised Of A Reservoir Into Which An Aerosol Medication Is Dispensed. A Holding Chamber Uses A Valved Mouthpiece Through Which The Patient Inhales The Dispensed Medication. Holding Chambers Are Intended To Minimize Delivery Of Large Aerosolized Particles.
| 510(k) Number | K181649 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 2018 |
| Decision Date | January 11, 2019 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | NVP - Holding Chambers, Direct Patient Interface |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5630 |
| Definition | Holding Chambers Are Devices That Are Used With Nebulizers And Metered Dose Inhalers And Are Comprised Of A Reservoir Into Which An Aerosol Medication Is Dispensed. A Holding Chamber Uses A Valved Mouthpiece Through Which The Patient Inhales The Dispensed Medication. Holding Chambers Are Intended To Minimize Delivery Of Large Aerosolized Particles |