BZH · Meter, Peak Flow, Spirometry

Anesthesiology · 21 CFR 868.1860 · Class 2

Overview

Product CodeBZH
Device NameMeter, Peak Flow, Spirometry
Regulation21 CFR 868.1860
Device ClassClass 2
Review PanelAnesthesiology
3rd-Party ReviewableYes

Identification

A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.

Classification Rationale

Class II (performance standards).

Recent Cleared Devices (20 of 79)

Showing 20 most recent of 79 cleared devices.

RecordDevice NameApplicantDecision DateDecision
K241338Peak Flow MeterChongqing Moffy Innovation Technology Co., Ltd.Dec 31, 2024SESE
K232588Aluna 2Knox Medical DiagnosticsNov 25, 2024SESE
K230423Electronic Peak Flow MeterTaian Dalu Medical Instrument Co., Ltd.Feb 23, 2024SESE
K222810TD-7301 Peak Flow meterGostar Co., Ltd.Dec 19, 2023SESE
K203196Peak flow meterShanghai Sonmol Medical Equipment Co., Ltd.May 26, 2021SESE
K200832Safey Peak Flow MeterSafey Medical Devices Pvt, Ltd.Jul 30, 2020SESE
K193311AlunaKnox Medical Diagnostics, Inc.Mar 25, 2020SESE
K191239Smart Peak Flow MeterGuangzhou Homesun Medical Technology Co., Ltd.Dec 6, 2019SESE
K180487Peak.meBreathe Me, Ltd.Oct 26, 2018SESE
K181666Smart OneMir Medical International ResearchAug 1, 2018SESE
K172804Besmed Peak Flow MeterBesmed Health Business CorpJan 11, 2018SESE
K170281MSA100BT Peak Flow MeterBeijing M&B Electronic Instruments Co., Ltd.Oct 6, 2017SESE
K152276Wing Smart FEVI and Peak Flow MeterSparo, Inc.Jun 3, 2016SESE
K133975MSA100 PEAK FLOW METERBeijing M&B Electronic Instruments Co., Ltd.Oct 3, 2014SESE
K123945STRIVE DUAL ZONE PEAK FLOW METERMonaghan Medical Corp.Apr 17, 2013SESE
K101380RXPEAKFLOWNoble MarketingSep 13, 2010SESE
K092335PEAK EXPIRATORY FLOW METER, KN-9710K-Jump Health Co., Ltd.Apr 9, 2010SESE
K091412CLEAN PEAK FLOW METERViasys Healthcare GmbHAug 21, 2009SESE
K082899DYNAMIPEAK PEAK FLOW METERDynamitech Medical, Inc.Mar 10, 2009SESE
K053156MINI-WRIGHT DIGITAL, MODEL 3120001Clement Clarke Intl., Ltd.Jan 31, 2006SESE

Top Applicants

Innolitics

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