Aerochamber M.V.
FDA 510(k) K884803 · Monaghan Medical Corp.
510(k) numberK884803
Submission
- Device name
- Aerochamber M.V.
- Applicant
- Monaghan Medical Corp.
Plattsburgh, NY, US - Received
- November 17, 1988
- Decision date
- April 26, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CAF – Nebulizer (Direct Patient Interface)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5630
- Specialty
- Anesthesiology
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| K023097 | Truezone Peak Flow MeterBZH · Abbreviated | 03/07/2003SE |
| K012939 | Aerovent II CHC Collapsible Holding ChamberCAF · Special | 09/28/2001SE |
| K991212 | Modification to Truzone Peak Flow MeterBZH · Abbreviated | 07/01/1999SE |
| K964130 | Aerogear Asthma Action KitBZH · Traditional | 01/10/1997SE |
| K963089 | Truzone Peak Flow MeterBZH · Traditional | 11/06/1996SE |
| K963095 | Trupeak Peak Flow MeterBZH · Traditional | 11/04/1996SE |
Questions and answers
When was Aerochamber M.V. cleared by the FDA?
Aerochamber M.V. (K884803) received a 510(k) decision of Substantially Equivalent on April 26, 1989, 160 days after the submission was received.
What is the product code of K884803?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.