Aerogear Asthma Action Kit
FDA 510(k) K964130 · Monaghan Medical Corp.
510(k) numberK964130
Submission
- Device name
- Aerogear Asthma Action Kit
- Applicant
- Monaghan Medical Corp.
Plattsburgh, NY, US - Received
- October 15, 1996
- Decision date
- January 10, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZH – Meter, Peak Flow, Spirometry
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1860
- Specialty
- Anesthesiology
Other 510(k)s with product code BZH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253180 | Microlife Digital Peak Flow Meter, Model PF200B (PF200B)BZH · Traditional | Microlife Corporation | 06/23/2026SE |
| K252802 | Peak Flow Meter (PF-10(BR-PEF231))BZH · Traditional | Shenzhen Bi-Rich Medical Devices Co., Ltd. | 05/29/2026SE |
| K241338 | Peak Flow MeterBZH · Traditional | Chongqing Moffy Innovation Technology Co., Ltd. | 12/31/2024SE |
| K232588 | Aluna 2BZH · Traditional | Knox Medical Diagnostics | 11/25/2024SE |
| K230423 | Electronic Peak Flow MeterBZH · Traditional | Taian Dalu Medical Instrument Co., Ltd. | 02/23/2024SE |
| K222810 | TD-7301 Peak Flow meterBZH · Traditional | Gostar Co., Ltd. | 12/19/2023SE |
| K203196 | Peak flow meterBZH · Traditional | Shanghai Sonmol Medical Equipment Co., Ltd. | 05/26/2021SE |
| K200832 | Safey Peak Flow MeterBZH · Traditional | Safey Medical Devices Pvt, Ltd. | 07/30/2020SE |
| K193311 | AlunaBZH · Traditional | Knox Medical Diagnostics, Inc. | 03/25/2020SE |
| K191239 | Smart Peak Flow MeterBZH · Traditional | Guangzhou Homesun Medical Technology Co., Ltd. | 12/06/2019SE |
More from Guangzhou Homesun Medical Technology Co., Ltd.
| 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 |
| K963089 | Truzone Peak Flow MeterBZH · Traditional | 11/06/1996SE |
| K963095 | Trupeak Peak Flow MeterBZH · Traditional | 11/04/1996SE |
| K955234 | Trupeak Peak Flow MeterBZH · Traditional | 03/18/1996SE |
Questions and answers
When was Aerogear Asthma Action Kit cleared by the FDA?
Aerogear Asthma Action Kit (K964130) received a 510(k) decision of Substantially Equivalent on January 10, 1997, 87 days after the submission was received.
What is the product code of K964130?
The FDA product code is BZH – Meter, Peak Flow, Spirometry, a Class II (moderate risk) device regulated under 21 CFR 868.1860.