BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent - Subject to Tracking Reg. 🇺🇸 United States

    BEAR CUB INFANT PRESSURE VENTILATOR

    K Number: K955865 · Decision Aug 6, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    26
    Review Days
    222

    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 CUB INFANT PRESSURE VENTILATOR
    K Number
    K955865
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent - Subject to Tracking Reg.
    Applicant
    Allied Healthcare Products, Inc.
    Date Received
    December 28, 1995
    Decision Date
    August 6, 1996
    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 Allied Healthcare Products, Inc.

    K Number Device Name
    K131098 EMERGENCY PORTABLE VENTILATOR
    K132021 AHP 300, EMERGENCY PORTABLE VENTILATOR
    K090356 EMERGENCY PORTABLE VENTILATOR, MODEL EPV200
    K083507 BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS
    K083385 MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B
    K080063 MASS CASUALTY VENTILATOR, MODEL MCV100
    K072214 PORTABLE VENTILATOR, MODEL EPV-100
    K073171 RESUSCITATION TIMER, MODEL L770-CPR
    K070636 AUTOVENT 4000 WITH CPAP
    K070120 AUTOVENT MODEL 4000
    Search all 26 clearances from Allied Healthcare Products, Inc. →