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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Meter, Peak Flow, Spirometry
510(k) Number K241338
Device Name Peak Flow Meter
Applicant
Chongqing Moffy Innovation Technology Co.,Ltd.
No.292 Jingdongfang Rd.Beibei Dist
Chongqing,  CN 400714
Applicant Contact Yongxu Li
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Room 1401, Dongfang Building, 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Eva Li
Regulation Number868.1860
Classification Product Code
BZH  
Date Received05/13/2024
Decision Date 12/31/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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