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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name amplifier, physiological signal
510(k) Number K202174
Device Name Digital NeuroPort Biopotential Signal Processing System
Applicant
Blackrock Microsystems
630 Komas Drive, Suite 200
Salt Lake City,  UT  84108
Applicant Contact Rachelle Frischknecht
Correspondent
Blackrock Microsystems
630 Komas Drive, Suite 200
Salt Lake City,  UT  84108
Correspondent Contact Rachelle Frischknecht
Regulation Number882.1835
Classification Product Code
GWL  
Subsequent Product Code
GWK  
Date Received08/04/2020
Decision Date 02/10/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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