Peak flow meter

FDA 510(k) K203196 · Shanghai Sonmol Medical Equipment Co., Ltd.

Substantially Equivalent

510(k) numberK203196

Submission

Device name
Peak flow meter
Applicant
Shanghai Sonmol Medical Equipment Co., Ltd.
Shanghai, CN
Received
October 28, 2020
Decision date
May 26, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

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)DeviceApplicantDecision
K253180Microlife Digital Peak Flow Meter, Model PF200B (PF200B)BZH · Traditional Microlife Corporation06/23/2026SE
K252802Peak Flow Meter (PF-10(BR-PEF231))BZH · Traditional Shenzhen Bi-Rich Medical Devices Co., Ltd.05/29/2026SE
K241338Peak Flow MeterBZH · Traditional Chongqing Moffy Innovation Technology Co., Ltd.12/31/2024SE
K232588Aluna 2BZH · Traditional Knox Medical Diagnostics11/25/2024SE
K230423Electronic Peak Flow MeterBZH · Traditional Taian Dalu Medical Instrument Co., Ltd.02/23/2024SE
K222810TD-7301 Peak Flow meterBZH · Traditional Gostar Co., Ltd.12/19/2023SE
K200832Safey Peak Flow MeterBZH · Traditional Safey Medical Devices Pvt, Ltd.07/30/2020SE
K193311AlunaBZH · Traditional Knox Medical Diagnostics, Inc.03/25/2020SE
K191239Smart Peak Flow MeterBZH · Traditional Guangzhou Homesun Medical Technology Co., Ltd.12/06/2019SE
K180487Peak.meBZH · Traditional Breathe Me, Ltd.10/26/2018SE

Questions and answers

When was Peak flow meter cleared by the FDA?

Peak flow meter (K203196) received a 510(k) decision of Substantially Equivalent on May 26, 2021, 210 days after the submission was received.

What is the product code of K203196?

The FDA product code is BZH – Meter, Peak Flow, Spirometry, a Class II (moderate risk) device regulated under 21 CFR 868.1860.