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

    MAX TRANSPORT VENTILATOR

    K Number: K900465 · Decision Jun 18, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    15
    Review Days
    138

    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
    MAX TRANSPORT VENTILATOR
    K Number
    K900465
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Hamilton Medical, Inc.
    Date Received
    January 31, 1990
    Decision Date
    June 18, 1990
    Product Code
    CBK
    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
    CBK Ventilator, Continuous, Facility Use

    Similar 510(k) Clearances

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

    Evita (V800); Evita (V600)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Inbentus Versatile

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VPAP Pediatric Face Mask

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Vivo 45 LS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SV600, SV800 Ventilator

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

    Other Clearances by Hamilton Medical, Inc.

    K Number Device Name
    K040574 GALILEO GOLD
    K001686 GALILEO VENTILATOR
    K982910 HAMILTON MEDICAL GALILEOVENTILATOR
    K990293 ALADDIN II MONITORING OXYGEN/AIR MONITOR
    K960359 ALADDIN MONITORING OXYGEN/AIR MIXER
    K945740 INFANT FLOW SYSTEM
    K901448 VEOLAR VENTILATOR
    K894426 LEONARDO INFORMATION SYSTEM
    K894316 AMADEUS VENTILATOR
    K881482 VEOLAR VENTILATOR
    Search all 15 clearances from Hamilton Medical, Inc. →