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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Noninvasive Positive Airway Pressure System, Facility Use
510(k) Number K251165
Device Name Saans (F4-01-00-000-000)
Applicant
Innaccel Technologies Private Limited
Aanand Towers, No-4, 5th Floor,Raja Rammohan Roy Rd.
Ward #77, Sampangi Rama Nagar
Bengaluru,  IN 560025
Applicant Contact Vijayarajan Alagumalai
Correspondent
Innaccel Technologies Private Limited
Aanand Towers, Municipal No 4,
Rajaram Mohan Roy Road, Ward 77, Sampangiramanagar
Bengaluru,  IN 560025
Correspondent Contact Vijayarajan Alagumalai
Regulation Number868.5895
Classification Product Code
SGR  
Date Received04/15/2025
Decision Date 01/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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