Smart Peak Flow Meter
FDA 510(k) K191239 · Guangzhou Homesun Medical Technology Co., Ltd.
510(k) numberK191239
Submission
- Device name
- Smart Peak Flow Meter
- Applicant
- Guangzhou Homesun Medical Technology Co., Ltd.
Guangzhou, CN - Received
- May 8, 2019
- Decision date
- December 6, 2019
- 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 |
| K180487 | Peak.meBZH · Traditional | Breathe Me, Ltd. | 10/26/2018SE |
More from Breathe Me, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K231561 | Pulmonary Function Tester, Model: A9BTY · Traditional | 02/21/2024SE |
Questions and answers
When was Smart Peak Flow Meter cleared by the FDA?
Smart Peak Flow Meter (K191239) received a 510(k) decision of Substantially Equivalent on December 6, 2019, 212 days after the submission was received.
What is the product code of K191239?
The FDA product code is BZH – Meter, Peak Flow, Spirometry, a Class II (moderate risk) device regulated under 21 CFR 868.1860.