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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 Rd.,
Longgang District
Shenzhen,  CN 518116
Applicant Contact Gloria Sun
Correspondent
Guangzhou Osmunda Medical Device Technical Service Co., Ltd.
8-9th Floor, R&D Bldg., #26 Qinglan St., 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
Predetermined Change
Control Plan Authorized		 No
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