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

    MASK, FACE, SURGICAL

    K Number: K770021 · Decision Jan 17, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    56
    Applicant Total
    5
    Review Days
    11

    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
    MASK, FACE, SURGICAL
    K Number
    K770021
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5880
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Precept, Inc.
    Date Received
    January 6, 1977
    Decision Date
    January 17, 1977
    Product Code
    CAD
    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
    CAD Vaporizer, Anesthesia, Non-Heated

    Similar 510(k) Clearances

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

    V80 Anesthetic Vaporizer (V80)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Tec 820, Tec 850

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    V60 Anesthetic Vaporizer

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SEVOFLURANE VAPORIZER ADAPTOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SIGMA ALPHA VAPORIZER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454

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

    Other Clearances by Precept, Inc.

    K Number Device Name
    K771409 DISP. SURGICAL FACE MASK
    K770463 MASK, SURGICAL, FACE, DISPOSABLE
    K770391 COVER, ARMBOARD, DISPOSABLE
    K760360 SHIRT, MITTEN CUFF INFANT