Monaghan Aerochamber
FDA 510(k) K822437 · Monaghan Medical Corp.
510(k) numberK822437
Submission
- Device name
- Monaghan Aerochamber
- Applicant
- Monaghan Medical Corp.
Walker, MI, US - Received
- August 13, 1982
- Decision date
- November 3, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BYP – Mouthpiece, Breathing
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5620
- Specialty
- Anesthesiology
Other 510(k)s with product code BYP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K955657 | North State Plastics Respiratory MouthpieceBYP · Traditional | North State Plastics, Inc. | 03/12/1996SE |
| K944512 | Truzone PFM Disposable MouthpieceBYP · Traditional | Monaghan Medical Corp. | 11/02/1994SE |
| K893791 | Breathing MouthpieceBYP · Traditional | Diemolding Corp. | 06/23/1989SE |
| K872037 | AerochamberBYP · Traditional | Monaghan Medical Corp. | 07/24/1987SE |
| K865093 | Safe-T-Shield MouthpieceBYP · Traditional | Medi Nuclear Corp., Inc. | 01/15/1987SE |
| K863049 | Inhalation AidBYP · Traditional | Boehringer Ingelheim Pharmaceuticals, Inc. | 10/15/1986SE |
| K862788 | MP-4400 Mouthpiece-Flange SealBYP · Traditional | Medipart Jerry Alexander | 08/01/1986SE |
| K853575 | Medipart Mouthpiece MP-1010BYP · Traditional | Medipart Jerry Alexander | 10/29/1985SE |
| K853574 | Medipart Dispos. Mouthpiece W/22MM O.D. MP-4411BYP · Traditional | Medipart Jerry Alexander | 10/29/1985SE |
| K853572 | Medipart Dispos. Mouthpiece W/2MM I.D. MP-4410BYP · Traditional | Medipart Jerry Alexander | 10/29/1985SE |
More from Medipart Jerry Alexander
| 510(k) | Device | Decision |
|---|---|---|
| K220145 | Monaghan medical filtered mouthpiece kitCAF · Traditional | 08/24/2023SE |
| K123945 | Strive Dual Zone Peak Flow MeterBZH · Traditional | 04/17/2013SE |
| K110273 | Aerovent Plus CHCCAF · Traditional | 06/09/2011SE |
| K031514 | Modification to Trupeak Peak Flow MeterBZH · Special | 05/23/2003SE |
| 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 Monaghan Aerochamber cleared by the FDA?
Monaghan Aerochamber (K822437) received a 510(k) decision of Substantially Equivalent on November 3, 1982, 82 days after the submission was received.
What is the product code of K822437?
The FDA product code is BYP – Mouthpiece, Breathing, a Class I (low risk) device regulated under 21 CFR 868.5620.