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

    KENDRO HERACELL 240 INCUBATOR

    K Number: K023465 · Decision Mar 10, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    45
    Applicant Total
    2
    Review Days
    146

    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
    KENDRO HERACELL 240 INCUBATOR
    K Number
    K023465
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6120
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kendro Laboratory Products, L.P.
    Date Received
    October 15, 2002
    Decision Date
    March 10, 2003
    Product Code
    MQG
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MQG Accessory, Assisted Reproduction

    Similar 510(k) Clearances

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

    Vacuum Pump (Model: AD-VPUM-500)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Harioculture TL-16 Time-lapse Incubator

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    EmbryoScope+

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Geri Embryo Incubator and Geri Dish

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Kendro Laboratory Products, L.P.

    K Number Device Name
    K002805 KENDRO HERACELL CO2 INCUBATOR