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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 K243926
Device Name Vivatmo pro-S
Applicant
Bosch Healthcare Solutions GmbH
Stuttgarter Straße 130
Waiblingen,  DE 71332
Applicant Contact Jeannette Stroh
Correspondent
Bosch Healthcare Solutions GmbH
Alte Bundesstrasse 50
Waiblingen,  DE 71332
Correspondent Contact Jeannette Stroh
Regulation Number862.3080
Classification Product Code
MXA  
Date Received12/20/2024
Decision Date 09/11/2025
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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