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510(k) Data Aggregation

    K Number
    K023354
    Device Name
    COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E
    Manufacturer
    SIEMENS ELEMA AB
    Date Cleared
    2003-09-05

    (333 days)

    Product Code
    BTI
    Regulation Number
    868.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIEMENS ELEMA AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of Compressor Mini is to provide a supply of dry, filtered, compressed air for a medical respiratory ventilator or anaesthesia machine that meets the specifications of the Compressor Mini. Its capacity is approximately 30 Vmin at 50-64 psi (350 - 450 kPa, 3.5 - 4.5 bar). Compressor Mini is intended to be operated by healthcare providers, physicians, nurses and technicians. Compressor Mini is intended to be used for bedside application in a hospital environment. Compressor Mini is not intended to be used during in-hospital transportation or during ambulance or air transportation.
    Device Description
    Compressor Mini will provide a supply of dry and filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meets the specifications of the Compressor Mini. Its capacity is approximately 30 Vimin at 50-64 psi (350 - 450 kPa). The compressor is of light weight and compact design. It runs quietly, which makes it suitable for bedside use. It may be employed as a primary or secondary source of compressed air. The Standby function assures that if the central gas supply fails the Compressor Mini will start to deliver compressed air. The Compressor Mini is fitted with two alarm parameters, temperature and pressure. The Compressor Mini is designed with the similar materials and technology as the predicate device ALRECO 40400.
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    K Number
    K010923
    Device Name
    KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E
    Manufacturer
    SIEMENS ELEMA AB
    Date Cleared
    2002-01-23

    (302 days)

    Product Code
    MHX
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIEMENS ELEMA AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K010925
    Device Name
    SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E
    Manufacturer
    SIEMENS ELEMA AB
    Date Cleared
    2001-12-18

    (266 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIEMENS ELEMA AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002137
    Device Name
    CATHCOR DESKTOP
    Manufacturer
    SIEMENS ELEMA AB
    Date Cleared
    2000-10-05

    (83 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIEMENS ELEMA AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001315
    Device Name
    MODIFICATION TO KION ANESTHESIA SYSTEM
    Manufacturer
    SIEMENS ELEMA AB
    Date Cleared
    2000-05-26

    (30 days)

    Product Code
    BSZ
    Regulation Number
    868.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIEMENS ELEMA AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K970839
    Device Name
    SERVO VENTILATOR 300A
    Manufacturer
    SIEMENS ELEMA AB
    Date Cleared
    1997-10-14

    (221 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIEMENS ELEMA AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use of the Servo Ventilator 300A is indicated for adult, pediatric or neonatal patient populations in an environment where patient care is provided by Healthcare Professionals (Physician, Nurse, Technician), when the professional determines that a device is required to assist the breathing of the patient. The device can be used both for controlling the entire ventilation for patients without any ability to breathe, as well as for supporting patients with reduced ability.
    Device Description
    The Servo Ventilator 300A is a modification of the Servo Ventilator 300 which was found Substantially Equivalent on October 25, 1996 (Premarket Notification K960010). The physical differences between the Servo Ventilator 300 and the Servo Ventilator 300A consist of a software change and adding of a new printed circuit board as well as a new switch and two LED's on the front panel. In the Servo Ventilator 300A a new functionality called Automode has been added, which is a method that, by using functionality from existing breathing modes, allows the patient to better interact with the ventilator. Each controlled mode has a corresponding supported mode. This gives the possibility for the ventilator to react on patient effort - triggering, and lack of effort - apnea. Essentially the ventilator can be set in two states, support or control. Which of these states that are active is determined by a pre-defined algorithm.
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    K Number
    K960010
    Device Name
    SERVO VENTILATOR 300 COMPUTER INTERFACE
    Manufacturer
    SIEMENS ELEMA AB
    Date Cleared
    1996-10-25

    (297 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIEMENS ELEMA AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Siemens Servo Ventilator 300 is intended for general and critical ventilatory care for use with neonatal, infant, pediatric, and adult patients The unit is designed to be used at the bedside and for in-hospital transport. It is not intended for transport use in ambulances or helicopters in the U.S. market. The intended use of the Computer Interface Board Version 2 is the same as for the Computer Interface Board Version 1. The CI board stores and transmits information about the ventilator to external digital devices via optically isolated serial interfaces.
    Device Description
    The Servo Ventilator 300 and Computer Interface Version 2 is a modification of the Servo Ventilator 300 and Computer Interface Version 1 which was found Substantially Equivalent on June 26, 1991 (Premarket Notification K902859). These modifications are being made to update the hardware design and to make additional software features available, while retaining the original functionality. The Servo Ventilator 300 Alarm and Monitoring Module has been modified to eliminate false or otherwise unnecessary alarms by eliminating the "Leakage Alarm" feature, and miscellaneous minor improvements to other alarm functions. This improves ease of use, and has the additional benefit of improving user vigilance when real alarms occur. The Computer Interface, CI, is an accessory circuit board that interfaces the ventilator to an external information-gathering system, such as a personal computer, via asynchronous serial lines. Information, such as trend data, real time parameter values, and technical information, is transferred to the external system via different commands. The modifications in the Version 2 hardware improve reliability and manufacturing efficiency. The modifications in the Version 2 software allow the user to select from a wider variety of data channels and add the transmission of checksums to ensure data integrity.
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    K Number
    K960168
    Device Name
    SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990
    Manufacturer
    SIEMENS ELEMA AB
    Date Cleared
    1996-10-25

    (283 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIEMENS ELEMA AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Servo Screen 390 is to provide a central bedside location for the display of all parameter information from the ventilator in order to aid the clinician in quickly and accurately reviewing the operating state of the ventilator and the ventilatory status of the patient.
    Device Description
    The Servo Screen 390 is a real time ventilatory monitor system that continuously reads and makes calculations from parameters measured or calculated by Servo Ventilators. It displays this information in a clear and logically organized manner. Parameters are listed in a numerical format and/or as waveforms and loops. All displayed parameters are trended in 3, 6, 12, or 24 hour intervals. The device consists of a small, compact computer unit suitable for use in the clinical environment designed specifically for integration with existing ventilators Servo Ventilator 300 and Servo Ventilator 900. The flat screen display unit measures 252 x 330 x 88 mm (not including control knob) and a flexible support arm. Weight including the support arm is 4.3 kg. When used with the Servo Ventilator 900, the Servo Computer Module 990 is required to interface the two devices. This interface mounts under the ventilator, adding 2.7 kg to the weight and 4.0 cm to the height.
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