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

    KONTRON PULSE OXIMETER 7840

    K Number: K873624 · Decision Oct 19, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    57
    Review Days
    407

    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
    KONTRON PULSE OXIMETER 7840
    K Number
    K873624
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Kontron Instruments, Inc.
    Date Received
    September 8, 1987
    Decision Date
    October 19, 1988
    Product Code
    DQA
    Advisory Committee
    Cardiovascular
    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
    DQA Oximeter

    Similar 510(k) Clearances

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

    Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AViTA Pulse Oximeter (SP61)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Kontron Instruments, Inc.

    K Number Device Name
    K932268 MODIFICATIONS TO INTRA-AORTIC BALLOONS
    K925248 MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS
    K923603 INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION
    K905313 KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II
    K903344 9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM)
    K896437 KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM
    K892222 9.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOON
    K882955 SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 7283
    K896386 MINIMON 7133B PATIENT MONITOR
    K896417 KONTRON KOLORMON 7250 PATIENT MONITOR
    Search all 57 clearances from Kontron Instruments, Inc. →