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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 K203196
Device Name Peak flow meter
Applicant
Shanghai Sonmol Medical Equipment Co., Ltd.
Rm. 116-118, Bldg. 21,#500 Jiajian Rd.,
Jiading District
Shanghai,  CN
Applicant Contact Li Yong Xu
Correspondent
Shanghai Sungo Management Consulting Company Limited.
14th F 1500# Century Ave.,
Shanghai,  CN 200122
Correspondent Contact Raymond Luo
Regulation Number868.1860
Classification Product Code
BZH  
Date Received10/28/2020
Decision Date 05/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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