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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Breath Nitric Oxide
510(k) Number K233775
Device Name Vivatmo pro
Applicant
Bosch Healthcare Solutions GmbH
Stuttgarter Strasse 130
Waiblingen,  DE 71332
Applicant Contact Carola Döffinger
Correspondent
Radcliffe Consulting, Inc.
231 Fairbanks St.
West Boylston,  MA  01583
Correspondent Contact Gail Radcliffe
Regulation Number862.3080
Classification Product Code
MXA  
Date Received11/24/2023
Decision Date 02/22/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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