Digital NeuroPort Biopotential Signal Processing System

Amplifier, Physiological Signal

Blackrock Microsystems

The following data is part of a premarket notification filed by Blackrock Microsystems with the FDA for Digital Neuroport Biopotential Signal Processing System.

Pre-market Notification Details

Device IDK202174
510k NumberK202174
Device Name:Digital NeuroPort Biopotential Signal Processing System
ClassificationAmplifier, Physiological Signal
Applicant Blackrock Microsystems 630 Komas Drive, Suite 200 Salt Lake City,  UT  84108
ContactRachelle Frischknecht
CorrespondentRachelle Frischknecht
Blackrock Microsystems 630 Komas Drive, Suite 200 Salt Lake City,  UT  84108
Product CodeGWL  
CFR Regulation Number882.1835 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-04
Decision Date2021-02-10

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