BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ZMACHINE, MODEL DT-100

    K Number: K101830 · Decision Mar 31, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    63
    Applicant Total
    2
    Review Days
    273

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ZMACHINE, MODEL DT-100
    K Number
    K101830
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Consolidated Research of Richmond, Inc.
    Date Received
    July 1, 2010
    Decision Date
    March 31, 2011
    Product Code
    OLV
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OLV Standard Polysomnograph With Electroencephalograph

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OLV), ordered by most recent decision date.

    Noxturnal Web

    FDA 510(k)
    FDA Class 2 ·Neurology

    Falcon HST

    FDA 510(k)
    FDA Class 2 ·Neurology

    Noxturnal Web

    FDA 510(k)
    FDA Class 2 ·Neurology

    HomeSleepTest (HST, HST REM+)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Cerebra Sleep System

    FDA 510(k)
    FDA Class 2 ·Neurology

    SOMNOscreen plus

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Consolidated Research of Richmond, Inc.

    K Number Device Name
    K142825 Zmachine