K-number	K241338
Device name	Peak Flow Meter
Applicant	Chongqing Moffy Innovation Technology Co., Ltd.
Product code	BZH
Device class	Class II
Decision date	Dec 31, 2024
Decision	Substantially Equivalent
Regulation	868.1860

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Peak Flow Meter (product code BZH) is an over-the-counter respiratory monitoring device designed for adults and children over 5 years of age. Multiple models (SMPF-1A through SMPF-3D) measure Peak Expiratory Flow (PEF) and some measure Forced Expiratory Volume (FEV1) in one second for home monitoring of respiratory conditions such as asthma.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Peak Flow Meter

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