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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleep Appliances With Patient Monitoring
510(k) Number K254304
Device Name iNOS intraoral biosensor
Applicant
Achaemenid, LLC
75 State St.
Suite 100
Boston,  MA  02109
Applicant Contact Reza Radmand
Correspondent
Aztech Regulatory & Quality, LLC
543 Long Hill Ave.
Shelton,  CT  06484
Correspondent Contact Joseph Azary
Regulation Number872.5570
Classification Product Code
PLC  
Subsequent Product Codes
DQA   LQZ   LRK   OUG  
Date Received12/31/2025
Decision Date 08/25/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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