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

    BEAR NICU-1

    K Number: K853346 · Decision Sep 11, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    60
    Applicant Total
    28
    Review Days
    30

    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 NICU-1
    K Number
    K853346
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1850
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Bear Medical Systems, Inc.
    Date Received
    August 12, 1985
    Decision Date
    September 11, 1985
    Product Code
    BZK
    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
    BZK Spirometer, Monitoring (W/Wo Alarm)

    Similar 510(k) Clearances

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

    BEACON Caresystem Model 00002144

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ExSpiron 2Xi

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Gas Module 3

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ExSpiron 1Xi

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ExSpiron 1Xi

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EXSPIRON 1XI

    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
    K900637 BEAR CEM CONTROLLER
    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
    Search all 28 clearances from Bear Medical Systems, Inc. →