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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Predicted Values, Pulmonary Function
510(k) Number K231561
Device Name Pulmonary Function Tester, Model: A9
Applicant
Guangzhou Homesun Medical Technology Co., Ltd.
Floor 7th, Tianxiang Business Bldg., #28, Li Fu Rd.
Haizhu District
Guangzhou,  CN 510250
Applicant Contact Suijie Huang
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center,
# 3101-90 Qianhai Rd.
Shenzhen,  CN 518052
Correspondent Contact Tracy Che
Regulation Number868.1890
Classification Product Code
BTY  
Date Received05/31/2023
Decision Date 02/21/2024
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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