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FDA 510(k)

Digital NeuroPort Biopotential Signal Processing System

K-Number: K202174 · 2021-02-10

ApplicantBlackrock Microsystems
Decision Date2021-02-10
Product CodeGWL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Digital NeuroPort Biopotential Signal Processing System is the device name listed in this FDA 510(k) record. The listed applicant is Blackrock Microsystems. It received FDA 510(k) clearance on 2021-02-10 under 510(k) number K202174. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Digital NeuroPort Biopotential Signal Processing System?

Digital NeuroPort Biopotential Signal Processing System is a medical device that received FDA 510(k) clearance on 2021-02-10. The listed applicant is Blackrock Microsystems. The 510(k) number is K202174.

When did Digital NeuroPort Biopotential Signal Processing System receive FDA 510(k) clearance?

Digital NeuroPort Biopotential Signal Processing System received FDA 510(k) clearance on 2021-02-10, under 510(k) number K202174.

Who is the listed applicant for Digital NeuroPort Biopotential Signal Processing System?

The FDA 510(k) record lists Blackrock Microsystems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digital NeuroPort Biopotential Signal Processing System?

The FDA product code for Digital NeuroPort Biopotential Signal Processing System is GWL.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT03567213Investigation on the Cortical Communication (CortiCom) SystemRECRUITINGNCT03161067Investigation on the Bidirectional Cortical Neuroprosthetic SystemRECRUITING

Other records listing Blackrock Microsystems as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K191346Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)

Related Devices (Code: GWL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243746Delphi AmplifierQuantalx NeroscienceK242832NExT Station; NExT Station AdvancedEb Neuro S.P.A.K242305BE Plus PRO, Neurotravel LIGHTEb Neuro S.P.A.K240646DreamClearSomnomed Technologies Inc., Doing Business AS RemwareK232210X-trodes System MX-TrodesK230148VlabDormotech Medical, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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