Agachamber Spacer
FDA 510(k) K101348 · Aga Plastic Ind. Com. Ltda.
510(k) numberK101348
Submission
- Device name
- Agachamber Spacer
- Applicant
- Aga Plastic Ind. Com. Ltda.
Great Neck, NY, US - Received
- May 13, 2010
- Decision date
- April 29, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NVP – Holding Chambers, Direct Patient Interface
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5630
- Specialty
- Anesthesiology
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
Other 510(k)s with product code NVP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242667 | AeroChamber2go Anti-Static Valved Holding ChamberNVP · Traditional | Trudell Medical International | 01/15/2025SE |
| K210558 | LiteAire Basic Dual-Valved, Collapsible MDI Holding ChamberNVP · Traditional | Thayer Medical Corporation | 04/01/2022SE |
| K181649 | AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)NVP · Traditional | Trudell Medical International | 01/11/2019SE |
| K160109 | Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding ChamberNVP · Traditional | Thayer Medical Corporation | 05/19/2017SE |
| K143615 | Antistatic Compact Space ChamberNVP · Traditional | Medical Developments International Limited | 01/26/2016SE |
| K140062 | FSC Anti-Static Valved Collapsible Holding ChamberNVP · Traditional | Fsc Laboratories, Inc. | 10/03/2014SE |
| K122252 | Space Chamber Plus Compact Space Chamber PlusNVP · Traditional | Medical Developments International | 11/13/2013SE |
| K130598 | Inspirachamber Anti-Static Valved Holding ChamberNVP · Traditional | Inspirx, Inc. | 06/05/2013SE |
| K112010 | Aerochamber Plus Flow-Vu Anti-Static Valved Holding Chamber (VHC)NVP · Traditional | Trudell Medical Intl. | 07/11/2012SE |
| K110293 | Optichamber Diamond Valved Holding ChamberNVP · Traditional | Respironics New Jersey, Inc. | 08/09/2011SE |
More from Respironics New Jersey, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K992995 | Aromatic and Flavored Tongue DepressorFMA · Traditional | 12/09/1999SE |
Questions and answers
When was Agachamber Spacer cleared by the FDA?
Agachamber Spacer (K101348) received a 510(k) decision of Substantially Equivalent on April 29, 2011, 351 days after the submission was received.
What is the product code of K101348?
The FDA product code is NVP – Holding Chambers, Direct Patient Interface, a Class II (moderate risk) device regulated under 21 CFR 868.5630.