BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    OLYMPIC BRAINZ MONITOR MODEL OBM70001

    K Number: K093949 · Decision Jun 16, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    15
    Applicant Total
    12
    Review Days
    175

    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
    OLYMPIC BRAINZ MONITOR MODEL OBM70001
    K Number
    K093949
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Natus Medical, Inc.
    Date Received
    December 23, 2009
    Decision Date
    June 16, 2010
    Product Code
    OMA
    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
    OMA Amplitude-Integrated Electroencephalograph

    Similar 510(k) Clearances

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

    Neo

    FDA 510(k)
    FDA Class 2 ·Neurology

    Nihon Kohden QP-160AK EEG Trend Program

    FDA 510(k)
    FDA Class 2 ·Neurology

    Cadwell AmpliScan

    FDA 510(k)
    FDA Class 2 ·Neurology

    Background Pattern Classification [BPc(TM)]

    FDA 510(k)
    FDA Class 2 ·Neurology

    NIHON KOHDEN AE-918P NEURO UNIT

    FDA 510(k)
    FDA Class 2 ·Neurology

    CEREBRALOGIK- AEEG

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

    Other Clearances by Natus Medical, Inc.

    K Number Device Name
    K093304 PROTEKTOR 32
    K090019 NATUS NEUROWORKS, MODEL 104196
    K083371 NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)
    K073665 ALGO 5 NEWBORN HEARING SCREENER
    K051869 NEOBLUE COZY LED PHOTOTHERAPY SYSTEM
    K030823 ALGO 3I NEWBORN HEARING SCREENER
    K022196 NATUS BLUE LIGHT PHOTOTHERAPY UNIT
    K013137 ALGO 3 NEWBORN HEARING SCREENER
    K974805 CO-STAT(TM) END TIDAL BREATH ANALYZER
    K935160 MINIMUFFS
    Search all 12 clearances from Natus Medical, Inc. →