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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spirometer, diagnostic
510(k) Number K222443
Device Name Air Smart Extra Spirometer
Applicant
FeelLife Health Inc.
Room 1903, Building A, No.9 Furong Road, Tantou Community
Songgang Subdistrict, Bao’an District
Shenzhen,  CN 518104
Applicant Contact May Xiao
Correspondent
Guangzhou Osmunda Medical Device Technical Service Co., Ltd.
8-9th Floor, R&D Building, No.26 Qinglan Street
Panyu District
Guangzhou,  CN 510006
Correspondent Contact Olivia Meng
Regulation Number868.1840
Classification Product Code
BZG  
Date Received08/12/2022
Decision Date 08/09/2023
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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