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

    POET OXIMETER

    K Number: K864745 · Decision Jun 2, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    18
    Applicant Total
    22
    Review Days
    179

    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
    POET OXIMETER
    K Number
    K864745
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1230
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Criticare Systems, Inc.
    Date Received
    December 5, 1986
    Decision Date
    June 2, 1987
    Product Code
    DQE
    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
    DQE Catheter, Oximeter, Fiber-Optic

    Similar 510(k) Clearances

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

    PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PreSep Oligon Oximetry Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN

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

    Other Clearances by Criticare Systems, Inc.

    K Number Device Name
    K101602 VITAL SIGNS MONITOR
    K091050 506CN PATIENT MONITOR
    K042569 8600 VITAL SIGNS MONITOR
    K030613 VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100
    K022435 507EL VITAL SIGNS MONITOR
    K012059 8100/8500 VITAL SIGNS MONITOR
    K001020 8100 VITAL SIGNS MONITOR
    K000276 MPT 24 AND VITAL VIEW 24
    K961223 MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS
    K944860 SCHOLAR PATIENT MONITOR
    Search all 22 clearances from Criticare Systems, Inc. →