K052332 is an FDA 510(k) clearance for the AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER. This device is classified as a Holding Chambers, Direct Patient Interface (Class II - Special Controls, product code NVP).
Submitted by Trudell Medical Intl. (London, CA). The FDA issued a Cleared decision on September 21, 2005, 26 days after receiving the submission on August 26, 2005.
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 | K052332 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 2005 |
| Decision Date | September 21, 2005 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| 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 |