BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    PURTIAN BENNETT, GOOD KNIGHT 420G MODEL M-113900-US; PURTAN BENNETT, GOODKNIGHT 420S MODEL M-113903-US

    K Number: K020886 · Decision Nov 1, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    459
    Applicant Total
    2
    Review Days
    228

    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
    PURTIAN BENNETT, GOOD KNIGHT 420G MODEL M-113900-US; PURTAN BENNETT, GOODKNIGHT 420S MODEL M-113903-US
    K Number
    K020886
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tyco Healthcare Nancy
    Date Received
    March 18, 2002
    Decision Date
    November 1, 2002
    Product Code
    BZD
    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
    BZD Ventilator, Non-Continuous (Respirator)

    Similar 510(k) Clearances

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

    Orion

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ResScan Essentials

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MySleepDash

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask

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

    Other Clearances by Tyco Healthcare Nancy

    K Number Device Name
    K031470 PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US