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

    MODEL PM-20(N)(R)CO2 PATIENT MONITOR/ALA

    K Number: K800869 · Decision May 28, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    304
    Applicant Total
    32
    Review Days
    41

    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
    MODEL PM-20(N)(R)CO2 PATIENT MONITOR/ALA
    K Number
    K800869
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Cavitron Corp.
    Date Received
    April 17, 1980
    Decision Date
    May 28, 1980
    Product Code
    CCK
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

    Similar 510(k) Clearances

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

    Capnostream™35 Portable Respiratory Monitor (PM35MN)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Medical Gas Analyzer (AG200)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AIM (N/A)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask

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

    Other Clearances by Cavitron Corp.

    K Number Device Name
    K811582 THE PLACER
    K810207 MINOR SURGERY LIGHT
    K802928 SPIROMETRIC COMPUTER #SC-10
    K801623 CAVITRON ULTRASONIC SURG. ASPIR. CUSA
    K801877 SLIT LAMP ATTACHMENT
    K800722 AUTO-FIELD D AUTOMATED VISUAL DETECTOR
    K791585 MODEL G-61 ULTRASONIC DENTAL UNIT
    K791277 MODEL 6500 EXTRACTION IRRIGATION SYS
    K782054 LASER, CO2 SURGICAL
    K782065 LASER, PHOTOCOAGULATION
    Search all 32 clearances from Cavitron Corp. →