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

    Certa Dose Pediatric Midazolam 5mg/mL IM Syringe

    K Number: K180683 · Decision Nov 7, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    237

    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
    Certa Dose Pediatric Midazolam 5mg/mL IM Syringe
    K Number
    K180683
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Certa Dose, Inc.
    Date Received
    March 15, 2018
    Decision Date
    November 7, 2018
    Product Code
    PQX
    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
    PQX Epinephrine Syringe

    Similar 510(k) Clearances

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

    Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe

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

    Other Clearances by Certa Dose, Inc.

    K Number Device Name
    K160589 Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe