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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ear, Nose, And Throat Image Analyzer
510(k) Number K261725
Device Name OtoCompanion (Version 1.0)
Applicant
Ironsides Medical, Inc.
1 Mifflin Pl.
Cambridge,  MA  02138
Applicant Contact Daphne Psacharopoulos
Correspondent
DuVal & Associates
825 Nicollet Mall
Suite 1820
Minneapolis,  MN  55402
Correspondent Contact Allison Komiyama
Classification Product Code
SHL  
Date Received05/26/2026
Decision Date 09/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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