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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K261633
Device Name VisuBreath
Applicant
Affirm Medical Technologies II, LLC
246 Sea View Ave.
Piedmont,  CA  94610
Applicant Contact Brian Cain
Correspondent
Jenelle N. Mohan, Esq
190 La Colina Dr.
Alamo,  CA  94507
Correspondent Contact Jenelle Mohan
Regulation Number868.1400
Classification Product Code
CCK  
Date Received05/18/2026
Decision Date 07/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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