BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MODUFLEX NEONATAL VENTILATOR SET

    K Number: K823479 · Decision Dec 15, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    87
    Applicant Total
    632
    Review Days
    22

    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
    MODUFLEX NEONATAL VENTILATOR SET
    K Number
    K823479
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5975
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    November 23, 1982
    Decision Date
    December 15, 1982
    Product Code
    BZO
    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
    BZO Set, Tubing And Support, Ventilator (W Harness)

    Similar 510(k) Clearances

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

    UNICOR, INC. CORRUGATED TUBING

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    UNICOR, INC. VENTILATOR HOSES

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    PRIMA VENTILATOR HOSES

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    PRIMA CUSTOM ANESTESIA CIRCUIT

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    PRIMA BREATHING BAGS

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    PRIMA VOLUMN VENTILATORSS

    FDA 510(k)
    FDA Class 1 ·Anesthesiology
    View all

    Other Clearances by Bd Becton Dickinson Vacutainer Systems Preanalytic

    K Number Device Name
    K003062 BACTEC MGIT 960 SIR KITS
    K003553 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
    K003461 BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE
    K002938 B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16
    K001364 BD DIRECTIGEN FLU A+B
    K000762 MOXIFLOXACIN, 5 UG, BBL SENSI-DISC
    K000829 GATIFLOXACIN, 5 UG, BBL SENSI-DISC
    K993186 SYNERCID, 15 UG, BBL SENSI-DISC
    K992734 BECTON DICKINSON SYRINGE
    K991551 VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE
    Search all 632 clearances from Bd Becton Dickinson Vacutainer Systems Preanalytic →