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510(k) Data Aggregation
K Number
K974903Device Name
GAS MODULE II, MODEL 0998-00-0143
Manufacturer
DATASCOPE CORP.
Date Cleared
1998-03-13
(72 days)
Product Code
CBS
Regulation Number
868.1620Why did this record match?
Product Code :
CBS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The indications for use for the Gas Module II include monitoring of airway gases, during anesthesia and/or assisted respiration. The intended environment of use is the anesthesia department, including the Operating Room (OR) and post anesthesia care units (PACU), etc.
Device Description
Not Found
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K Number
K953795Device Name
VITALMAX 4100
Manufacturer
PACE TECH, INC.
Date Cleared
1996-07-01
(322 days)
Product Code
CBS
Regulation Number
868.1620Why did this record match?
Product Code :
CBS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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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?
Product Code :
CBS
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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