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

    HEMOSONIC 200HEMODYNAMIC MONITOR

    K Number: K040802 · Decision Apr 28, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    110
    Review Days
    30

    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
    HEMOSONIC 200HEMODYNAMIC MONITOR
    K Number
    K040802
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.3700
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arrow Intl., Inc.
    Date Received
    March 29, 2004
    Decision Date
    April 28, 2004
    Product Code
    DPN
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DPN Thin Layer Chromatography, Propoxyphene

    Other Clearances by Arrow Intl., Inc.

    K Number Device Name
    K100635 ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504
    K093050 ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520
    K071491 ARROW INTERNATIONAL, INC., SURGICAL DRAPES
    K071998 ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT
    K071111 NON-ABSORBABLE SILK SUTURE
    K060309 AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES
    K042126 PICC
    K041153 SHARPSAWAY II LOCKING DISPOSABLE CUP
    K040801 INTRA-AORTIC BALLOON (IAB)
    K040100 ARROW ECHOGENIC INTRODUCER NEEDLE
    Search all 110 clearances from Arrow Intl., Inc. →