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

    OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM

    K Number: K073656 · Decision Jan 25, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    73
    Applicant Total
    2
    Review Days
    30

    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
    OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM
    K Number
    K073656
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hypermed, Inc.
    Date Received
    December 26, 2007
    Decision Date
    January 25, 2008
    Product Code
    MUD
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MUD Oximeter, Tissue Saturation

    Similar 510(k) Clearances

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

    Spectrum-2

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Masimo O3 Regional Oximeter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Lap.Ox™ Laparoscopic Tissue Oximeter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Cerebral Autoregulation Index (CAI) Algorithm

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ODI-Tech

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SnapshotNIR model KD205

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

    Other Clearances by Hypermed, Inc.

    K Number Device Name
    K061848 HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU1