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510(k) Data Aggregation
K Number
K955026Device Name
AS/3 NMT MODULE
Manufacturer
DATEX MEDICAL INSTRUMENTATION, INC.
Date Cleared
1997-04-28
(543 days)
Product Code
KOI
Regulation Number
868.2775Why did this record match?
Applicant Name (Manufacturer) :
DATEX MEDICAL INSTRUMENTATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The product is designed to be used for monitoring relaxation of patient during and after anesthesia and for regional block stimulation for nerve location. The intended environment of use is anesthesia department, including operation rooms (OR) and post-anesthesia care units (PACU) etc.
Device Description
The AS/3™ NMT Module is a part of the modular anesthesia monitoring system AS/3™. It provides relaxation measurement of patient. The NMT measurement hardware is in the NMT Module stimulates the Mores the patient controlled by the Net Compact Monitor central unit. The News NMT Module measures the respon responses from the NMT module, calculates the NMT values, displays the NMT values, handles NMT trending and NMT monitor features.
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K Number
K961063Device Name
AS/3 CARDIAC OUTPUT & SVO2 MODULE
Manufacturer
DATEX MEDICAL INSTRUMENTATION, INC.
Date Cleared
1996-05-31
(74 days)
Product Code
DQK
Regulation Number
870.1425Why did this record match?
Applicant Name (Manufacturer) :
DATEX MEDICAL INSTRUMENTATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AS/3TM COPSv module is intended to be used in the Datex AS/3TM Anaesthesia Monitor or in the AS/3TM Compact Monitor in anesthesia department, in intensive care department etc.
Device Description
The AS/3TM COPSv Module is a parts of the modular anesthesia monitoring system AS/3™. It provides cardiac output (C.O.), right ventricular ejection fraction (REF), mixed venous oxygen saturation (SvO2) and invasive measurement of patient.
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K Number
K960490Device Name
AS/3 COMPACT AIRWAY MODULE M-CAIOV
Manufacturer
DATEX MEDICAL INSTRUMENTATION, INC.
Date Cleared
1996-05-03
(91 days)
Product Code
CBS
Regulation Number
868.1620Why did this record match?
Applicant Name (Manufacturer) :
DATEX MEDICAL INSTRUMENTATION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AS/31M Compact Airway Module M-CAiOV is intended to be used in the Datex AS/3TM Anesthesia Monitor or in the AS/3TM Compact Monitor in anesthesia department, including operation rooms (OR) and post-anesthesia care units (PACU) etc.
Device Description
The AS/3TM Compact Airway Module M-CAiOV is a part of the modular anesthesia monitoring system AS/3TM. It measures carbon dioxide (CO2), nitrous oxide (N2O), oxygen (O2) and anesthetic agent concentration (AA) of respiratory gases. The Airway Module also identifies anesthetic agent (ID) and measures airway pressure and volume (pV).
The sampled gases are analyzed by an infrared photometer and a paramagnetic oxygen sensor. Respiratory rate is derived from the CO2 signal. The anesthetic agents (halothane, enflurane, isoflurane, desflurane and sevoflurane) are identified from the sampled gases with infrared technique. Airway gas flow is measured with the aid of a pneumotachometer type transducer and airway pressure is measured from the same adapter by means of a pressure transducer.
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