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

    NEEDLE COUNTER-SURE COUNT/30 CT. MAGN.

    K Number: K801257 · Decision Jun 4, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    9
    Applicant Total
    17
    Review Days
    7

    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
    NEEDLE COUNTER-SURE COUNT/30 CT. MAGN.
    K Number
    K801257
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.2620
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Kleen Test Products
    Date Received
    May 28, 1980
    Decision Date
    June 4, 1980
    Product Code
    BXX
    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
    BXX Calibrator, Pressure, Gas

    Similar 510(k) Clearances

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

    SINGLE DOSE GAS INJECTOR

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    RT-200 COMPUTER INTERFACE

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    UTAH PRESSURE TRANSDUCER CALIBRATOR TRU-CAL

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    RT-200 CALIBRATION ANALYZER

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    NEEDLE COUNTER-SURE COUNT-DISPOSA-TRAY

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    NEEDLE COUNTER-SURE COUNT/10 COUNT

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

    Other Clearances by Kleen Test Products

    K Number Device Name
    K890039 KLEEN TEST BASIN SET
    K890539 SURE COUNT LIGHT HANDLE COVER
    K890098 KLEEN TEST O.R. KIT
    K853622 SURE COUNT 30 COUNT FOAM & MAGNETIC 92-3030
    K853454 SURE COUNT 5 & 10 SPONGE COUNTER
    K853315 CAUTERY TIP CLEANING PAD
    K852258 SURE-COUNT 30 COUNT MAGNETIC NEEDLE COUNTER
    K852257 SURE-COUNT 15 COUNT NEEDLE COUNTER
    K844199 ELASTIC STYLE IMPERVIOUS ORTHOPEDIC STOCKINET
    K821396 OUT-RITE WASTE DISPOSABLE BAG
    Search all 17 clearances from Kleen Test Products →