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510(k) Data Aggregation
K Number
K983366Device Name
TRIP TONOMETRY CATHETER, 16F
Manufacturer
DATEX-ENGSTROM, INC.
Date Cleared
1998-12-23
(90 days)
Product Code
KNT, CBR, CCK
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
DATEX-ENGSTROM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trip® Tonometry Catheter, 16 F (with stopcock) is used for the determination of regional PCO2 (PrCO>) and intramucosal pH (pHi) of the gastric mucosal tissue. This catheter is also used as a gastrointestinal tract access device for connecting the Tonocap™ monitor. The sampling line and biofilter (which are separate from the device) serve as a means of connecting the catheter to the Tonocap™ monitor and as a transducer protector to prevent patient cross-contamination and to prevent monitor damage, respectively. Since it incorporates a vented gastric sump, the catheter is also used for feeding and/or decompression or aspiration of the contents of the stomach.
The device is indicated for use in surgical/operating room patients, intensive care unit patients, emergency/trauma patients and hospital patients with suspected mesenteric ischemia
The Trip® Tonometry Catheter, 16 F (with biofilter and sampling line) is used for the determination of regional PCO2 (PrCO2) and intramucosal pH (pHi) of the gastric mucosal tissue when used as a gastrointestinal tract access device for connecting the Tonocap™ monitor. The sampling line and biofilter serve as a means of connecting the catheter to the Tonocap™ monitor and as a transducer profector to prevent patient cross-contamination and to prevent monitor damage, respectively. Since it incorporates a vented gastric sump, the catheter is also used for feeding and/or decompression or aspiration of the contents of the stomach.
The device is indicated for use in surgical/operating room patients, intensive care unit patients, emergency/trauma patients and hospital patients with suspected mesenteric ischemia
Device Description
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K Number
K982091Device Name
CS/3 COMPACT AIRWAY MODULE, M-COVX
Manufacturer
DATEX-ENGSTROM, INC.
Date Cleared
1998-12-22
(190 days)
Product Code
MHX
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
DATEX-ENGSTROM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For monitoring hospital patient's respiration (CO2, O2, N2O and respiration rate) ventilation (airway pressure, volume and flow) and gas exchange status (Oxygen Consumption VO2, Carbon (an way production VCO2, Respiratory Quotient RQ, and Energy Expenditure, EE). The system is intended for use by qualified medical personnel only.
Device Description
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K Number
K981378Device Name
DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1
Manufacturer
DATEX-ENGSTROM, INC.
Date Cleared
1998-11-03
(201 days)
Product Code
DRT
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
DATEX-ENGSTROM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Datex-Engstrom Light Monitor, F-LM1, F-LMP1 is for stationary and mobile monitoring of patient's ECG, SpO2, body temperature, invasive and non-invasive blood pressures as well as respiration and CO2 in hospitals and ambulances. When used outdoors, the monitor must be in the protective case.
Device Description
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K Number
K973985Device Name
AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU)
Manufacturer
DATEX-ENGSTROM, INC.
Date Cleared
1998-10-30
(375 days)
Product Code
BSZ
Regulation Number
868.5160Why did this record match?
Applicant Name (Manufacturer) :
DATEX-ENGSTROM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AS/3™ Anaesthesia Delivery Unit (AS/3™ ADU) is an Anesthesia Gas Machine for The A.J. > Anaesthetic breathing gas and manual or mechanical ventilation for patients undergoing anesthesia.
The AS/3™ ADU is indicated for all persons that require inhalation anesthesia.
The AS/3™ ADU shall be operated by qualified anesthesia personnel.
Device Description
AS/3™ Anaesthesia Delivery Unit (AS/3TM ADU) is an Anesthesia Gas Machine.
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K Number
K980362Device Name
MRI COMPATIBLE MONITOR AND ACCESSORIES
Manufacturer
DATEX-ENGSTROM, INC.
Date Cleared
1998-06-30
(152 days)
Product Code
DPS
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
DATEX-ENGSTROM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Datex-Engstrom MRI Patient Monitor and accessories is indicated for monitoring of ECG waveform for Heart Rate and Asystole detection, SpO22, Non-invasive blood pressure (NIBP), airway gases, anesthetic agents, airway flow, airway pressure and airway volume on patients during MR imaging. It is indicated for use inside the MRI room mounted outside the 20 Gauss line and with magnets of field strength 1.5 Tesla or less.
SpO2monitoring is indicated only with the use of Datex-Engstrom sensors specifically designed for use in the MRI environment. ECG monitoring is indicated only with use of the MRI ECG lead set.
Device Description
MRI Patient Monitor and Accessories
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K Number
K974792Device Name
CS/3(TM) MONITORS*
Manufacturer
DATEX-ENGSTROM, INC.
Date Cleared
1998-06-02
(162 days)
Product Code
DSI
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
DATEX-ENGSTROM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CS/3TMMonitors are indicated for multiparameter patient monitoring in all hospital patients.
Device Description
CS/3™ Monitors* * Includes CS/3™ Critical Care Monitor and CS/3™ Compact Monitor.
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K Number
K980384Device Name
TRIP TONOMETRY CATHETER, 18F
Manufacturer
DATEX-ENGSTROM, INC.
Date Cleared
1998-05-01
(88 days)
Product Code
CCK, CBR, KNT
Regulation Number
868.1400Why did this record match?
Applicant Name (Manufacturer) :
DATEX-ENGSTROM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TRIP Tonometry Catheter, 18F is used for the determination of regional PCO2 (PrCO2) and intramucosal pH (pHi) of the gastric mucosal tissue when used as a gastrointestinal tract access device for connecting the Tonocap™ monitor. The sampling line and biofilter built into the device serve as a means of connecting the catheter to the TONOCAP™ monitor and as transducer protector to prevent patient cross-contamination and monitor damage, respectively. Since it incorporates a vented gastric sump it is also used for feeding and/or decompression or aspiration of the contents of the stomach. It is indicated for use in surgical/operating room patients, intensive care unit patients , emergency / trauma patients and hospital patients with suspected mesenteric ischemia.
Device Description
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K Number
K974747Device Name
CS/3 ARRHYTHMIA WORKSTATION
Manufacturer
DATEX-ENGSTROM, INC.
Date Cleared
1998-04-23
(125 days)
Product Code
DSI
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
DATEX-ENGSTROM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CS/3™ Arrythmia Workstation (ARRWS) is indicated for centralized monitoring, arrhythmia analysis and detection, waveform data storage and patient data storage in hospitalized patients connected to Datex-Engstrom monitors.
Device Description
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K Number
K974101Device Name
DATEX-ENGSTROM NETWORK
Manufacturer
DATEX-ENGSTROM, INC.
Date Cleared
1998-02-06
(99 days)
Product Code
MSX
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
DATEX-ENGSTROM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Datex-Engstrom Network transfers information between networked Datex-Engstrom devices. It allows a networked device to display, store, print and otherwise process information received from other networked devices.
The Datex-Engstrom Information Centre maintains the network connections between the Datex-Engstrom bedside monitors and other networked devices in Datex-Engstrom Network. Furthermore, it coordinates the transfer of information between devices in the Datex-Engstrom Network as well as between the Datex-Engstrom Network and Hospital Information Systems (HIS).
The Datex-Engstrom Information Centre can be used for storing, printing, viewing or otherwise processing of information from several bedside monitors or other networked devices.
The Datex-Engstrom Network will be used for patients in the hospital and it is meant for continuous use.
Device Description
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