510(k) K112010
K112010 is an FDA 510(k) premarket notification submitted by Trudell Medical Intl. for the device "AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC)". The FDA issued a decision of Substantially Equivalent on July 11, 2012. The device falls under product code NVP (Holding Chambers, Direct Patient Interface), a Class II device regulated under 21 CFR 868.5630. Trudell Medical Intl. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 11, 2012
- Date Received
- July 14, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Holding Chambers, Direct Patient Interface
- Device Class
- Class II
- Regulation Number
- 868.5630
- Review Panel
- AN
- Submission Type
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