510(k) K070674
K070674 is an FDA 510(k) premarket notification submitted by Trudell Medical Intl. for the device "AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR". The FDA issued a decision of Substantially Equivalent on April 11, 2007. 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
- April 11, 2007
- Date Received
- March 12, 2007
- Clearance Type
- Special
- 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