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

    PORTABLE INFANT VENTILATOR

    K Number: K771368 · Decision Aug 4, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    3
    Applicant Total
    32
    Review Days
    10

    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
    PORTABLE INFANT VENTILATOR
    K Number
    K771368
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Cavitron Corp.
    Date Received
    July 25, 1977
    Decision Date
    August 4, 1977
    Product Code
    FOC
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FOC Bag, Urine Collection, Newborn

    Similar 510(k) Clearances

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

    PREMIE U-BAG URINE SPECIMEN COLLECTOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    RIMECO MIDSTREAM URINE COLLECTOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Cavitron Corp.

    K Number Device Name
    K811582 THE PLACER
    K810207 MINOR SURGERY LIGHT
    K802928 SPIROMETRIC COMPUTER #SC-10
    K801623 CAVITRON ULTRASONIC SURG. ASPIR. CUSA
    K801877 SLIT LAMP ATTACHMENT
    K800869 MODEL PM-20(N)(R)CO2 PATIENT MONITOR/ALA
    K800722 AUTO-FIELD D AUTOMATED VISUAL DETECTOR
    K791585 MODEL G-61 ULTRASONIC DENTAL UNIT
    K791277 MODEL 6500 EXTRACTION IRRIGATION SYS
    K782054 LASER, CO2 SURGICAL
    Search all 32 clearances from Cavitron Corp. →