FDA.report

510(k) K230423

Device
Electronic Peak Flow Meter
Applicant
Taian Dalu Medical Instrument Co., Ltd.
510(k) number
K230423
Product code
BZH
Decision
Substantially Equivalent (SESE)
Decision date
2024-02-23
Date received
2023-02-17
Regulation
868.1860
Classification name
Meter, Peak Flow, Spirometry
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Wang Yuqin
Address
West Part Of Yitianmen St., Hi-Tech Zone Taian City CN 271000 271000

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code BZH

510(k)DeviceApplicantDecision date
K241338Peak Flow MeterChongqing Moffy Innovation Technology Co., Ltd.2024-12-31
K232588Aluna 2Knox Medical Diagnostics2024-11-25
K222810TD-7301 Peak Flow meterGostar Co., Ltd.2023-12-19
K203196Peak flow meterShanghai Sonmol Medical Equipment Co., Ltd.2021-05-26
K200832Safey Peak Flow MeterSafey Medical Devices Pvt, Ltd.2020-07-30
K193311AlunaKnox Medical Diagnostics, Inc.2020-03-25
K191239Smart Peak Flow MeterGuangzhou Homesun Medical Technology Co., Ltd.2019-12-06
K180487Peak.meBreathe Me, Ltd.2018-10-26
K181666Smart OneMir Medical International Research2018-08-01
K172804Besmed Peak Flow MeterBesmed Health Business Corp2018-01-11
K170281MSA100BT Peak Flow MeterBeijing M&B Electronic Instruments Co., Ltd.2017-10-06
K152276Wing Smart FEVI and Peak Flow MeterSparo, Inc.2016-06-03
K133975MSA100 PEAK FLOW METERBeijing M&B Electronic Instruments Co., Ltd.2014-10-03
K123945STRIVE DUAL ZONE PEAK FLOW METERMonaghan Medical Corp.2013-04-17
K101380RXPEAKFLOWNoble Marketing2010-09-13