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

    NGM GAS MODULE

    K Number: K911647 · Decision Sep 19, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    21
    Applicant Total
    55
    Review Days
    157

    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
    NGM GAS MODULE
    K Number
    K911647
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1500
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Datex Division Instrumentarium Corp.
    Date Received
    April 15, 1991
    Decision Date
    September 19, 1991
    Product Code
    CBQ
    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
    CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)

    Similar 510(k) Clearances

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

    PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OHMEDA MODEL 5330 ANESTHETIC MONITOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DATASCOPE MULTINEX II

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE

    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. →