BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇮 Finland

    AS/3 TM NETWORK

    K Number: K933284 · Decision Jul 11, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    304
    Applicant Total
    55
    Review Days
    370

    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
    AS/3 TM NETWORK
    K Number
    K933284
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Datex Division Instrumentarium Corp.
    Date Received
    July 6, 1993
    Decision Date
    July 11, 1994
    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 Datex Division Instrumentarium Corp.

    K Number Device Name
    K953175 AS/3 ESTPR MODULE
    K961247 AS/3 LIGHT MONITOR
    K943458 AS/3 AIRWAY MODULE
    K945234 AS/3 MEMORY MODULE, M0MEM
    K933156 DATEX AS/3 PATIENT MONITOR
    K933285 DATEX AS/3 TM ANAESTHESIA MONITOR
    K943456 AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT
    K923172 ANAESTHESIA RECORD KEEPER
    K935477 AS/3(TM) ANESTHESIA MONITOR SYST INTERFACE BOARD
    K943457 AS/3 PRESSURE TEMPERATURE MODULE, M-PT
    Search all 55 clearances from Datex Division Instrumentarium Corp. →