510(k) K101348
K101348 is an FDA 510(k) premarket notification submitted by Aga Plastic Ind. Com. Ltda. for the device "AGACHAMBER SPACER". The FDA issued a decision of Substantially Equivalent on April 29, 2011. The device falls under product code NVP (Holding Chambers, Direct Patient Interface), a Class II device regulated under 21 CFR 868.5630. Aga Plastic Ind. Com. Ltda. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 2011
- Date Received
- May 13, 2010
- 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