BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    NEO NEST

    K Number: K112547 · Decision Mar 6, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    377
    Registration Numbers
    377
    Same Product Code
    81
    Applicant Total
    1
    Review Days
    187

    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
    NEO NEST
    K Number
    K112547
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5710
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Denovo Proucts, LLC
    Date Received
    September 1, 2011
    Decision Date
    March 6, 2012
    Product Code
    IMD
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IMD Pack, Hot Or Cold, Disposable

    Similar 510(k) Clearances

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

    InfaTherm Disposable Infant Warming Mattress

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Infant Transport Mattress Warmer with Disc

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    EYEFEEL OPHTHALMIC WARMER

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    EYEFEEL OPHTHALMIC WARMER

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ALLEGIANCE PORTA-WARM MATTRESS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine
    View all