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

    IPCO M-101 ECHOCARDIOGRAPH (IPCO ULTRA-

    K Number: K792373 · Decision Feb 13, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    77
    Applicant Total
    23
    Review Days
    79

    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
    IPCO M-101 ECHOCARDIOGRAPH (IPCO ULTRA-
    K Number
    K792373
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Ipco Corp.
    Date Received
    November 26, 1979
    Decision Date
    February 13, 1980
    Product Code
    DXK
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DXK Echocardiograph

    Similar 510(k) Clearances

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

    Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IN-VISION IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    9750 ATHENA ETHERNET OPTION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCESSORY TO GENESIS III (GCFM)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600

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

    Other Clearances by Ipco Corp.

    K Number Device Name
    K871270 PERFORM DENTURE BASE RESIN
    K850666 STROBEX ULTRON ELECTROSURGE-DENTAL UNIT
    K850906 TACTILE PLUS DENTAL ELEVATORS
    K842836 SAFE & SOFT MINI PADS & MAXI PADS
    K842837 SAFE & SOFT MAXI SHILEDS
    K842838 SAFE & SOFT PANTY SHIELDS
    K841953 ULTRA SHIELD BRIEFS
    K840753 AMBEZE DISPOSABLE INCONTINENCE PANTS
    K840754 MAXISHIELD INCONTINENCE CARE SYSTEM
    K840755 MINIGARD DISPOSABLE LINERS
    Search all 23 clearances from Ipco Corp. →