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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety
510(k) Number K233337
Device Name Freespira Breathing System
Applicant
Freespira, Inc.
12020 113th Ave. NE, Suite 215
Kirkland,  WA  98034
Applicant Contact Thomas Simon
Correspondent
Freespira, Inc.
12020 113th Ave. NE, Suite 215
Kirkland,  WA  98034
Correspondent Contact Simon Thomas
Regulation Number882.5050
Classification Product Code
SEN  
Date Received09/29/2023
Decision Date 04/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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