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

    TRANSTAR PRESSURE TRANSDUCER

    K Number: K942377 · Decision Aug 16, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    47
    Applicant Total
    48
    Review Days
    90

    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
    TRANSTAR PRESSURE TRANSDUCER
    K Number
    K942377
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medex, Inc.
    Date Received
    May 18, 1994
    Decision Date
    August 16, 1994
    Product Code
    DPT
    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
    DPT Probe, Blood-Flow, Extravascular

    Similar 510(k) Clearances

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

    Laser Speckle Imaging System (RFLSI CZW)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Deltex Medical KDP72 Doppler Probe

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIO-PROBE TRANSDUCER (ADULT)

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

    Other Clearances by Medex, Inc.

    K Number Device Name
    K042432 PHARMGUARD TOOLBOX, MODEL G6000782
    K040899 MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP
    K020780 TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP
    K000328 MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP
    K982640 MEDEX 3000 SERIES SYRINGE INFUSION PUMP
    K982123 CONTRAST CONTROL DEVICE
    K955231 MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP
    K961404 MX960 REUSABLE PRESSURE TRANSDUCER
    K961527 MX703 AND MX730 CONTINUOUS FLUSH DEVICES
    K954970 STOPCOCK & LUER LOCK PLUG
    Search all 48 clearances from Medex, Inc. →