Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007323246

FEI Number

3007323246

Entity Name

Blackrock Microsystems

City/State/Country

Salt Lake City, UT, US

Establishment Address

630 S Komas Dr Ste 200, Salt Lake City, UT 84108, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Blackrock Microsystems (Owner Number: 10027942)

Owner / Operator Contact Address

630 Komas Drive, Suite 200, Salt Lake City, UT 84108, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K070272

PMA Number

N/A

All Registered Proprietary Names

Blackrock NeuroPort Biopotential signal Processing System NeuroPort Array NeuroPort Recording Microelectrode Neural Signal Monitoring System NeuroPort Neural Signal Processor Neural Signal Monitoring System NeuroPort Neural Signal Processing Digital NeuroPort Biopotential Signal Processing System Cervello NeuroPort Array NeuroPort Electrode

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWL	Amplifier, Physiological Signal	Neurology	Class 2	882.1835	2009-07-07
GZL	Electrode, Depth	Neurology	Class 2	882.1330	2008-12-16
GWL	Amplifier, Physiological Signal	Neurology	Class 2	882.1835	2008-12-16
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2008-12-16
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2008-12-16
GWL	Amplifier, Physiological Signal	Neurology	Class 2	882.1835	2021-04-08
GWK	Conditioner, Signal, Physiological	Neurology	Class 2	882.1845	2021-04-08
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2017-06-26
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2017-06-26
GWK	Conditioner, Signal, Physiological	Neurology	Class 2	882.1845	2017-06-26
GWL	Amplifier, Physiological Signal	Neurology	Class 2	882.1835	2017-06-26
GZL	Electrode, Depth	Neurology	Class 2	882.1330	2008-12-16

Official Correspondent

Matthew Trebella

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Blackrock Microsystems

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K161650	Neurotronics, Inc.	Polysmith Sleep System, Model NTI7593	2017-01-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2008	Bio-Logic Systems Corp	2	Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.

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3020018	CADWELL INDUSTRIES, INC.	KENNEWICK, WA, US
3010762896	NEUROELECTRICS BARCELONA S.L.U.	Barcelona Catalonia, ES
3005713796	G.TEC MEDICAL ENGINEERING GMBH	SCHIEDLBERG Oberosterreich, AT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007323246. Last updated year: 2026. Please use registration number 3007323246 when referencing this establishment in official correspondence.