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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 K191239
Device Name Smart Peak Flow Meter
Guangzhou Homesun Medical Technology Co., Ltd
Floor 7th, TianxiangBusiness Building,
No.28, Li Fu Road, Haizhu District
Guangzhou,  CN 510250
Applicant Contact Jinqun Li
Feiying Drug & Medical Consulting Technical Service Group
B-3F 3005, Bldg.1, Southward Ruifeng Business Center, No. 22
Guimiao Rd.
Shenzhen,  CN 518000
Correspondent Contact Tracy Che
Regulation Number868.1860
Classification Product Code
Date Received05/08/2019
Decision Date 12/06/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No