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

    CWD/PPG MODULE

    K Number: K896500 · Decision Jul 18, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    52
    Applicant Total
    12
    Review Days
    246

    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
    CWD/PPG MODULE
    K Number
    K896500
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2780
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Life Sciences Manufacturing, Inc.
    Date Received
    November 14, 1989
    Decision Date
    July 18, 1990
    Product Code
    JOM
    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
    JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

    Similar 510(k) Clearances

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

    PADnet Xpress

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MESI mTABLET TBI diagnostic system, MESI mTABLET TBI

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ASI Plethysmogrpah Analyzer

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Automated ankle brachial pressure index measuring device, MESI mTABLET system

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VitalScan ANS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Automated ankle brachial pressure index measuring device

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

    Other Clearances by Life Sciences Manufacturing, Inc.

    K Number Device Name
    K910905 SFA-II MICROPROCESSOR-CONTROLLED MODULE
    K903700 IPG-II MODULE
    K900365 PAG MICROPROCESSOR-CONTROLLED MODULE
    K895588 PORTABLE AIR PLETHYSMOGRAPH
    K896528 SFA MODULE
    K884624 MVL/MODULAB WITH PVR MODULE
    K873041 A-V RECORDER
    K832679 NON-INVASIVE CLINICAL VASCULAR LAB
    K822522 CUTANEOUS PRESSURE PLETHYSMOGRAPH
    K811560 AUTOMATED PHYSIOLOGIC PROFILE MONITOR
    Search all 12 clearances from Life Sciences Manufacturing, Inc. →