Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Blackrock Microsystems. It received FDA 510(k) clearance on 2021-02-10 under approval 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. It is manufactured by Blackrock Microsystems. The 510(k) number is K202174.

When was Digital NeuroPort Biopotential Signal Processing System approved by the FDA?

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

What company makes Digital NeuroPort Biopotential Signal Processing System?

Digital NeuroPort Biopotential Signal Processing System is manufactured by Blackrock Microsystems.

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

NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07614581 Intra-Sessional Autonomic Arc Detection in Ketamine-Assisted Therapy for PTSD: A Signal Characterisation Pilot Study NOT_YET_RECRUITING NCT06100393 New Algorithms to Signal Processing for Speech Enhancement in Adult Cochlear Implant Recipients. ACTIVE_NOT_RECRUITING NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING NCT06834217 Transcranial Direct Current Stimulation and Extinction in Obsessive Compulsive Disorder RECRUITING NCT07557147 Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41734979 Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review. Yonsei medical journal (2026) PMID: 41491965 From stones to system: integrating kidney stones disease into the cardiovascular-kidney-metabolic continuum. Current opinion in nephrology and hypertension (2026)

Other Devices by Blackrock Microsystems

K191346Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)

Related Devices (Code: GWL)

K171397Sienna Ultimate Wireless AmplifierEms Handels Gesellschaft M.B.H. K171669g.Nautilus PROG.Tec Medical Engineering GmbH K172312eego amplifiersEemagine Medical Imaging Solutions GmbH K2017478-CH Electroencephalography AmplifierHipposcreen Neurotech Corp. K203331Quick-20mCgx, LLC K220631NomadAir PMU810Neurotronics, Inc.

Official Source

View on FDA Database →

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

↑