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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 K183089
Device Name Air Next
Applicant
NuvoAir AB
17D Riddargatan
Stockholm,  SE 11457
Applicant Contact Max Ladow
Correspondent
Smith Associates
1468 Harwell Ave
Crofton,  MD  21114
Correspondent Contact Yolanda Smith
Regulation Number868.1840
Classification Product Code
BZG  
Date Received11/06/2018
Decision Date 01/02/2020
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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