Peak Expiratory Flow Meter, KN-9710
FDA 510(k) K092335 · K-Jump Health Co., Ltd.
510(k) numberK092335
Submission
- Device name
- Peak Expiratory Flow Meter, KN-9710
- Applicant
- K-Jump Health Co., Ltd.
Taipei Hsien, TW - Received
- August 4, 2009
- Decision date
- April 9, 2010
- 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 |
|---|---|---|
| K180714 | Probe Covers for ThermometersFLL · Abbreviated | 09/24/2018SE |
| K170262 | Digital ThermometerFLL · Abbreviated | 09/28/2017SE |
| K141505 | Basal Digital ThermometerFLL · Special | 08/26/2014SE |
| K121520 | Ultrasonic Nebulizer (Mesh Type)CAF · Abbreviated | 03/15/2013SE |
| K120711 | Non-Contact ThermometerFLL · Traditional | 11/19/2012SE |
| K103617 | Digital Forehead ThermometerFLL · Special | 04/04/2011SE |
| K102947 | Non-Contact Infrared ThermometerFLL · Traditional | 02/25/2011SE |
| K092806 | Auto Digital Upper Arm Blood Pressure Monitor, Model KP-7770DXN · Special | 10/09/2009SE |
| K083256 | Ultrasonic Nebulizer System, Model KN-9210CAF · Abbreviated | 06/26/2009SE |
| K083753 | Smart-Logic Auto Digital Upperarm Blood Pressure Monitor, Model KP-7500, Fully Fuzzy…DXN · Abbreviated | 06/19/2009SE |
Questions and answers
When was Peak Expiratory Flow Meter, KN-9710 cleared by the FDA?
Peak Expiratory Flow Meter, KN-9710 (K092335) received a 510(k) decision of Substantially Equivalent on April 9, 2010, 248 days after the submission was received.
What is the product code of K092335?
The FDA product code is BZH – Meter, Peak Flow, Spirometry, a Class II (moderate risk) device regulated under 21 CFR 868.1860.