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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 K201493
Device Name Spirometer
Applicant
MeHow Innovative Ltd
Block A&B&C, NCBC Industrial Park, 6th Baolong Road,
Longgang District
Shenzhen,  CN 518116
Applicant Contact Gloria Sun
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 Received06/04/2020
Decision Date 06/10/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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