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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 K213611
Device Name Fenom Pro
Applicant
CAIRE Diagnostics Inc.
7020 Koll Center Parkway Suite 110
Pleasanton,  CA  94566
Applicant Contact Ryan Leard
Correspondent
CAIRE Diagnostics Inc.
7020 Koll Center Parkway Suite 110
Pleasanton,  CA  94566
Correspondent Contact Ryan Leard
Regulation Number862.3080
Classification Product Code
MXA  
Date Received11/15/2021
Decision Date 06/07/2023
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
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