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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
Shanghai Sonmol Medical Equipment Co., Ltd.
Room 116-118, Building 21,No.500 Jiajian Road,
Jiading District
Shanghai,  CN
Applicant Contact Li Yong Xu
Shanghai Sungo management Consulting Company Limited
14th F, 1500# Century Avenue
Shanghai,  CN 200122
Correspondent Contact Raymond Luo
Regulation Number868.1860
Classification Product Code
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