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

    GAS EVACUATION ACCESSORY

    K Number: K852772 · Decision Oct 10, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    42
    Applicant Total
    63
    Review Days
    105

    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
    GAS EVACUATION ACCESSORY
    K Number
    K852772
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5430
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Siemens Elema AB
    Date Received
    June 27, 1985
    Decision Date
    October 10, 1985
    Product Code
    CBN
    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
    CBN Apparatus, Gas-Scavenging

    Similar 510(k) Clearances

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

    Nitronox Scavenger Plus

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Dynamic Gas Scavenging System 2 (DGSS - 2)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MINISCAV

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ISO-GARD MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ISO-GARD MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ISO-GARD CLEARAIR MASK

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

    Other Clearances by Siemens Elema AB

    K Number Device Name
    K023354 COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E
    K010923 KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E
    K010925 SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E
    K002137 CATHCOR DESKTOP
    K001315 MODIFICATION TO KION ANESTHESIA SYSTEM
    K970839 SERVO VENTILATOR 300A
    K960010 SERVO VENTILATOR 300 COMPUTER INTERFACE
    K960168 SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990
    K872278 SIEMENS O2-AIR MIXER 965
    K871354 SERVO VENTILATOR 900 C/D
    Search all 63 clearances from Siemens Elema AB →