Microlife Electronic Peak Flow Monitor, Model PF-100
FDA 510(k) K031024 · Microlife Corp.
510(k) numberK031024
Submission
- Device name
- Microlife Electronic Peak Flow Monitor, Model PF-100
- Applicant
- Microlife Corp.
Great Neck, NY, US - Received
- March 31, 2003
- Decision date
- November 14, 2003
- 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 |
|---|---|---|
| K261082 | Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)DXN · Traditional | 07/23/2026SE |
| K253180 | Microlife Digital Peak Flow Meter, Model PF200B (PF200B)BZH · Traditional | 06/23/2026SE |
| K251120 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress…DXN · Traditional | 08/06/2025SE |
| K122013 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Cardio+ (BP4GAPO-2M)DXN · Traditional | 05/13/2013SE |
| K080337 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MQ1-2DDXN · Traditional | 05/13/2008SE |
| K073398 | Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BP W100)DXN · Special | 12/20/2007SE |
| K073397 | Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H (BP A50)DXN · Special | 12/20/2007SE |
| K041411 | Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-APDXN · Traditional | 07/21/2004SE |
| K030961 | Microlife Digital Basal Thermometer, Model MT 1921LHD · Traditional | 09/12/2003SE |
| K021305 | Microlife Wrist Watch Blood Pressure, Model BP-3BU1-5, with Optional Thermal PrinterDXN · Special | 06/28/2002SE |
Questions and answers
When was Microlife Electronic Peak Flow Monitor, Model PF-100 cleared by the FDA?
Microlife Electronic Peak Flow Monitor, Model PF-100 (K031024) received a 510(k) decision of Substantially Equivalent on November 14, 2003, 228 days after the submission was received.
What is the product code of K031024?
The FDA product code is BZH – Meter, Peak Flow, Spirometry, a Class II (moderate risk) device regulated under 21 CFR 868.1860.