FDA.report

510(k) K241338

Device
Peak Flow Meter
Applicant
Chongqing Moffy Innovation Technology Co., Ltd.
510(k) number
K241338
Product code
BZH
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-31
Date received
2024-05-13
Regulation
868.1860
Classification name
Meter, Peak Flow, Spirometry
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Related Records

Applicant Contact

Contact
Yongxu Li
Address
#292 Jingdongfang Rd. Beibei Dist Chongqing CN 400714 400714

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

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