BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Blackrock Microsystems

    Reg #: 3007323246 · FEI: 3007323246 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    11
    Establishment Types
    3
    Classifications
    7

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    Registration Details

    Registration Name
    Blackrock Microsystems
    Registration Number
    3007323246
    FEI Number
    3007323246
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    630 S Komas Dr Ste 200
    City
    Salt Lake City
    State
    UT
    ZIP
    84108
    Country
    US

    Regulatory Submissions

    510(k) Number
    K090957

    Owner / Operator

    Firm Name
    Blackrock Microsystems
    Operator Number
    10027942
    Address
    630 Komas Drive, Suite 200
    City
    Salt Lake City
    State
    UT
    Postal Code
    84108
    Country
    US
    Correspondent
    Matthew Trebella

    Products

    Device Name Product Code
    Amplifier, Physiological Signal GWL
    Electrode, Depth GZL
    Full-Montage Standard Electroencephalograph GWQ
    Reduced- Montage Standard Electroencephalograph OMC
    Conditioner, Signal, Physiological GWK
    Standard Polysomnograph With Electroencephalograph OLV
    Electrode, Cortical GYC

    Proprietary Names

    Blackrock NeuroPort Biopotential signal Processing System NeuroPort Array NeuroPort Recording Microelectrode Neural Signal Monitoring System NeuroPort Neural Signal Processor NeuroPort Neural Signal Processing Digital NeuroPort Biopotential Signal Processing System Cervello NeuroPort Electrode XactStrip, XactGrid, and XactTrode NeuroPort Electrode (SIROF)

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility