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

    Elite Biomedical Solutions Dose Request Cord

    K Number: K220695 · Decision Apr 29, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    47
    Applicant Total
    1
    Review Days
    51

    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
    Elite Biomedical Solutions Dose Request Cord
    K Number
    K220695
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Elite Biomedical Solutions
    Date Received
    March 9, 2022
    Decision Date
    April 29, 2022
    Product Code
    MRZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MRZ Accessories, Pump, Infusion

    Similar 510(k) Clearances

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

    UTC 3mL Medication Cartridge

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RG 3ml Medication Cartridge

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BlueStar Rx

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SpaceStation MRI

    FDA 510(k)
    FDA Class 2 ·General Hospital

    WellDoc BlueStar

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Lockbox for Perfusor Space PCA Infusion Pump

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all