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

    BEAR CEM CONTROLLER

    K Number: K900637 · Decision Aug 3, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    28
    Review Days
    175

    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
    BEAR CEM CONTROLLER
    K Number
    K900637
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Bear Medical Systems, Inc.
    Date Received
    February 9, 1990
    Decision Date
    August 3, 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 Bear Medical Systems, Inc.

    K Number Device Name
    K992788 BEAR CUB 750 PSV
    K983981 BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBE
    K912619 BEAR 7 VENTILATOR
    K896315 BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY
    K893034 VHS 820 HUMIDIFIER, MODIFICATION
    K890724 MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR
    K882764 BEAR EVC-100 CONTROLLER
    K881335 BEAR 3 VENTILATOR
    K872660 BEAR NVM-1
    K873634 BEAR VH-820 HUMIDIFIER
    Search all 28 clearances from Bear Medical Systems, Inc. →