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

    KOI PACHYMETER

    K Number: K843247 · Decision Apr 30, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    398
    Registration Numbers
    399
    Same Product Code
    408
    Applicant Total
    7
    Review Days
    618

    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
    KOI PACHYMETER
    K Number
    K843247
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Koi, Inc.
    Date Received
    August 20, 1984
    Decision Date
    April 30, 1986
    Product Code
    ITX
    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
    ITX Transducer, Ultrasonic, Diagnostic

    Similar 510(k) Clearances

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

    ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)

    FDA 510(k)
    FDA Class 2 ·Radiology

    ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Mendaera Guidance System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Accuro® 3S Needle Guide Kit

    FDA 510(k)
    FDA Class 2 ·Radiology

    Ultrasound Transducer Cover

    FDA 510(k)
    FDA Class 2 ·Radiology

    UltraDrape UGPIV Barrier and Securement (34-15)

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

    Other Clearances by Koi, Inc.

    K Number Device Name
    K830366 DIAMOND KNIFE
    K812764 KOI BLUE FIELD ENTOPTOSCOPE
    K812450 KOI DIAMOND KNIFE
    K812097 KOI LACREMAL HOOK & DILATOR
    K812011 BLADE GAUGE
    K812010 KOI LACRIMAL INTUBATION SYSTEM