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

    SUPRASTERNAL NOTCH DOP/TRANS. 3MHZ

    K Number: K854591 · Decision Apr 23, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    37
    Applicant Total
    111
    Review Days
    156

    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
    SUPRASTERNAL NOTCH DOP/TRANS. 3MHZ
    K Number
    K854591
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1540
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Philips Medical Systems, Inc.
    Date Received
    November 18, 1985
    Decision Date
    April 23, 1986
    Product Code
    JAF
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JAF Monitor, Ultrasonic, Nonfetal

    Similar 510(k) Clearances

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

    Laminar P1 (LDH-HW-001)

    FDA 510(k)
    FDA Class 2 ·Radiology

    THD REVOLUTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    SIMPLEABI

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIFEDOP MODEL 300ABI

    FDA 510(k)
    FDA Class 2 ·Radiology

    THD SLIDE ONE

    FDA 510(k)
    FDA Class 2 ·Radiology

    THD SLIDE

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

    Other Clearances by Philips Medical Systems, Inc.

    K Number Device Name
    K093355 PCR ELEVA 1.2
    K090808 PINNACLE3 SMARTARC
    K071391 PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521
    K063783 PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A
    K041741 M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN
    K040955 M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN
    K040404 HEARTSTART MRX, MODEL M3535A
    K040357 M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A TELEMETRY MONITORING SYSTEM II
    K032979 PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T
    K033715 PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER
    Search all 111 clearances from Philips Medical Systems, Inc. →