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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, biofeedback
510(k) Number K180173
Device Name Freespira
Palo Alto Health Sciences, Inc.
12020 113th Ave NE, Building C, Suite 215
Kirkland,  WA  98034
Applicant Contact Simon Thomas
AcKnowledge Regulatory Strategies, LLC
2834 Hawthorn St.
San Diego,  CA  92104
Correspondent Contact Allison Komiyama
Regulation Number882.5050
Classification Product Code
Subsequent Product Code
Date Received01/22/2018
Decision Date 08/23/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No