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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 K182874
Device Name Fenom Pro Nitric Oxide Test
Applicant
Spirosure, Inc.
7020 Koll Center Pkwy. Suite 110
Pleasanton,  CA  94566
Applicant Contact Ryan Leard
Correspondent
Ammirati Regulatory Consulting
575 Shirlynn Ct.
Los Angeles,  CA  94022
Correspondent Contact Erika Ammirati
Regulation Number862.3080
Classification Product Code
MXA  
Date Received10/12/2018
Decision Date 02/13/2019
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
Recalls CDRH Recalls
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