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

    SKIN SAVER(TM) TUBING HOLDER, MODEL 467

    K Number: K912197 · Decision Aug 20, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    263
    Registration Numbers
    263
    Same Product Code
    41
    Applicant Total
    2
    Review Days
    95

    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
    SKIN SAVER(TM) TUBING HOLDER, MODEL 467
    K Number
    K912197
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5340
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Alpine Specialties, Inc.
    Date Received
    May 17, 1991
    Decision Date
    August 20, 1991
    Product Code
    CAT
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CAT Cannula, Nasal, Oxygen

    Similar 510(k) Clearances

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

    NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    NASAL CANNULA

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    4 SURE TM NASAL OXYGEN CANNULA

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    CANNULA NASAL OXYGEN

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    NASAL OXYGEN CANNULA, 81585, 81587 & 81589

    FDA 510(k)
    FDA Class 1 ·Anesthesiology
    View all

    Other Clearances by Alpine Specialties, Inc.

    K Number Device Name
    K921496 SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED