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510(k) Data Aggregation

    K Number
    K121886
    Device Name
    SAVINA 300 SAVINA 300, COUNTRY VARIANTS
    Manufacturer
    DRAEGER MEDICAL GMBH
    Date Cleared
    2014-08-08

    (771 days)

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

    DRAEGER MEDICAL GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Savina 300 is a ventilator intended for the ventilation of adults and pediatric patients starting from 5 kg (111bs) bodyweight. Savina 300 offers mandatory ventilation modes supporting spontaneous breathing, and airway monitoring. Savina 300 is intended for the following environments of use: - In intensive care wards, recovery rooms and generally for hospital use - During the transport of ventilated patients within the hospital - During secondary transport from one hospital to another (without trolley, monitor not mounted on Savina 300) - During transport flights with aircraft (without trolley, monitor is not mounted on Savina 300)
    Device Description
    Savina 300 is a turbine driven ventilator with a 12.1" color touch screen for easy handling, providing tube and mask based ventilation capabilities. Air is taken from ambient. O2 can be taken from central gas supply, bottle supply (with appropriated accessories) or from another low pressure oxygen source (LPO). The ventilation unit of the Savina 300 is a microprocessor-controlled ventilator. The Savina 300 provides overpressure ventilation and adjustable oxygen concentration with pressureand volume-controlled automatic and spontaneous breathing modes.
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    K Number
    K133886
    Device Name
    PERSEUS A500
    Manufacturer
    DRAEGER MEDICAL GMBH
    Date Cleared
    2014-06-20

    (182 days)

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

    DRAEGER MEDICAL GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The anesthesia workstation Perseus is intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. Perseus is equipped with airway monitoring, gas measurement and device monitoring, O2 insufflation, and an anesthetic gas receiving system. Anesthesia is achieved through a mixture of pure oxygen and Air (medical compressed air) or pure oxygen and nitrous oxide, with the addition of volatile anesthetic agents. Ventilation is accomplished on the patient through a laryngeal mask, a mask, or an endotracheal tube. The integrated breathing system can be used with partial rebreathing (low-flow or minimumflow). A non-rebreathing system such as the Kuhn or Medec Water System may be used at the external fresh-gas outlet (optional). Perseus A500 is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions.
    Device Description
    The Perseus A500 is a continuous flow gas anesthesia system that delivers anesthetic vapour, provides for automatic and manual modes of ventilation, and is equipped with a monitoring system for ventilation, inspired and expired gas, and agent identification. The main functionality of the anesthesia system comprises - gas delivery for mixing oxygen and carrier gases, - - anesthetic agent delivery (via vaporizers such as Dräger Vapor 3000), - anesthesia ventilator (blower based), - - anesthesia breathing system ABS, - - airway monitoring (flow, pressure, gas concentrations) . The Perseus A500 consists of the following main components: - M3 Blower based Anesthesia Ventilator, electrical driven, supporting the Ventilation . modes - o Man/Spont - o Volume Controlled - Pressure Controlled o - Embedded control display with touch screen technology and rotary/confirm knob for selecting and confirming parameters. - . Gas Mixer - . Heated integrated Anaesthesia Breathing System ABS - Patient Gas Monitoring with agent mixture detection and Oxygen monitoring . - Integrated Anesthesia Gas Scavenging System - - Auxiliary Oxygen Therapy w/ flow indicator - - Oxygen cylinder support (reserve gas inlet) -
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    K Number
    K121999
    Device Name
    GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE
    Manufacturer
    DRAEGER MEDICAL GMBH
    Date Cleared
    2013-02-28

    (234 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    DRAEGER MEDICAL GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    General Purpose Temperature probes Dräger disposable general purpose temperature probes are intended for patient core body temperature measurement in combination with Dräger and Siemens patient monitoring systems. The probes are inserted into the oesophagus or the rectum. Skin Temperature probes Dräger disposable skin temperature probes are intended for patient skin temperature measurement in combination with Dräger and Siemens patient monitoring systems. The probes are affixed on the patient's skin with an adhesive cover.
    Device Description
    Temperature probes are used during patient temperature measurement and consist of a plug connected to a patient monitor and a thermistor on the patient end. The thermistor consists of a resistor which is sensitive to temperature changes. The portfolio includes General Purpose Temperature probes to be inserted into the oesophagus or the rectum and Skin Temperature Probes. The devices are intended for single patient use and can be used with Dräger and Siemens patient monitors.
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    K Number
    K103035
    Device Name
    SMARTPILOT VIEW MODEL MK04500
    Manufacturer
    DRAEGER MEDICAL GMBH
    Date Cleared
    2012-03-28

    (532 days)

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

    DRAEGER MEDICAL GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SmartPilot View is software which monitors and logs the dosage of intravenous and volatile drugs administered to a human being. Additionally, SmartPilot View displays pharmacokinetic, pharmacodynamic (PK/PD) and interactive PD modeling information. Smart Pilot provides the health care professional with theoretical information about the modeled effect of supported anesthesia pharmaceuticals delivered to the patient. The SmartPilot View is software for use by health care professionals trained in the application of general anaesthesia. The SmartPilot View is intended for use with data from adults only. The demographic ranges for these patient data are as follows: Height 59 in to 79 in (150 cm to 200 cm) Weight 88 lb to 309 lb (40 kg to 140 kg) Age 18 to 90 years
    Device Description
    The current version of the SmartPilot View is receiving data from a dedicated anesthesia workstation or combination of workstation and other devices. The Software SmartPilot View runs on a dedicated patient vincinity workstation (Draeger C700 for IT) with the installed Infinity Explorer Software. The data is taken from dedicated anesthesia workstation A (Draeger Primus US "Apollo") or combination of the workstation and other devices like IV Pumps (B.Braun Perfusor Space pump) and patient monitors M (Draeger Delta/Delta XL, Kappa, Omega S). The software visualizes the drug effect based on pharmacokinetic models and the drug interaction based on pharmacodynamic models known from scientific literature. The software visualizes the synergetic and additive drug effect on a screen in a specially developed 2D pharmacodynamic diagram. Furthermore a new pharmacodynamic parameter (NSRI) is calculated based on the synergetic drug effects. The software monitors and calculates data for the use during the anesthesia case. The software also logs data during the anesthesia case for a retrospective analysis. Supported drugs: Intravenous hypnotics – Propofol Volatile hypnotics - Isoflurane - Sevoflurane - Desflurane - Enflurane Intravenous opioids - Fentanyl - Remifentanil - Sufentanil - Alfentanil Intravenous muscle relaxants - Pancuronium - Rocuronium Parameters provided by the basic device (monitor and anaesthesia machine) - Heart rate HR in 1/min - Mean non-invasive blood pressure NIBP M or mean arterial pressure ART M in mmHg or kPa. - End-expiratory CO2 concentration etCO2 in mmHg, Vol.% or kPa. - Bispectral index BIS - BIS signal quality index SQI in %
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