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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Tremor
510(k) Number K213519
Device Name Rune Labs Tremor Transducer System
Applicant
Rune Labs, Inc.
649 Iriving St.
San Francisco,  CA  94122
Applicant Contact Brian Pepin
Correspondent
Anacapa Clinical Research, Inc.
2421 Sunset Dr.
Ventura,  CA  93001
Correspondent Contact Courtney Lane
Regulation Number882.1950
Classification Product Code
GYD  
Subsequent Product Codes
ISD   NXQ  
Date Received11/03/2021
Decision Date 06/10/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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