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

    GOODKNIGHT 425ST

    K Number: K050072 · Decision Jun 13, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    459
    Applicant Total
    42
    Review Days
    152

    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
    GOODKNIGHT 425ST
    K Number
    K050072
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nellcor Puritan Bennett, Inc.
    Date Received
    January 12, 2005
    Decision Date
    June 13, 2005
    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 Nellcor Puritan Bennett, Inc.

    K Number Device Name
    K070408 DURAMAX REUSABLE OXIMETRY SENSOR
    K060576 NELLCOR OXIMAX N-600X PULSE OXIMETER
    K051271 OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR
    K052186 NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P
    K051352 OXIMAX NPB-40 HANDHELD PULSE OXIMETER
    K033973 OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR
    K030787 SHILEY FLEXTRA TRACHEOSTOMY TUBE
    K030930 OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N
    K023494 NELLCOR INDGO MANUAL RESUSCITATOR
    K022819 NELLCOR N-200 PULSE OXIMETER, MODEL N-200
    Search all 42 clearances from Nellcor Puritan Bennett, Inc. →