Search Results
Found 5 results
510(k) Data Aggregation
K Number
K040862Device Name
GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM
Manufacturer
CARADYNE, LTD.
Date Cleared
2004-06-30
(89 days)
Product Code
BZD, CBK
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
CARADYNE, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended to provide CPAP for use in hospitals to treat newborns and infants less than 5kg body weight with RDS or which are recovering from RDS (Respiratory Distress Syndrome). May or may not include humidification capabilities.
Device Description
The Guardian Neonate CPAP / Humidification systems is non-invasive respiratory support device for neonatal patients
Ask a Question
K Number
K023565Device Name
OXICHECK
Manufacturer
CARADYNE, LTD.
Date Cleared
2003-03-28
(156 days)
Product Code
CCL
Regulation Number
868.1720Why did this record match?
Applicant Name (Manufacturer) :
CARADYNE, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OxiCheck is intended as a tool for use by qualified personnel to check or measure oxygen concentration of a delivered air / oxygen mixture. The OxiCheck is not intended for use in breathing systems and is not intended for patient monitoring. It is not intended to be used to continuously monitor or confirm oxygen delivery to a patient. The OxiCheck is intended to be used in hospitals, Sub-acute Institutions, Transport, and Home care. The OxiCheck is not intended for use in a MRI environment.
Device Description
The OxiCheck is a disposable oxygen analyzer that checks the oxygen concentration (also called fractional inspired oxygen, FiO2) of a delivered air/oxygen mixture.
Ask a Question
K Number
K000959Device Name
CRITERION 60 OR PM 60
Manufacturer
CARADYNE, LTD.
Date Cleared
2000-06-22
(90 days)
Product Code
CAP
Regulation Number
868.2600Why did this record match?
Applicant Name (Manufacturer) :
CARADYNE, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K992101Device Name
CRITERION 40 OR PM 40
Manufacturer
CARADYNE, LTD.
Date Cleared
2000-01-06
(198 days)
Product Code
CAP
Regulation Number
868.2600Why did this record match?
Applicant Name (Manufacturer) :
CARADYNE, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Is intended to measure airway pressure when used with positive pressure devices. The device alarms when the airway pressure falls outside of the user selected high and low alarm limits and displays peak pressure and real-time airway pressures. It may be used with positive pressure devices which do not include pressure measurement capabilities, e.g. resuscitation bags or basic ventilators, or as an independent backup pressure monitor for devices with pressure measurement capability. Environment of use is hospital, home, and sub-acute institutions. The device has been designed for stationary and intra-institution transport only.
Device Description
The Criterion 40 is a microprocessor controlled device that measures and monitor patient airway pressure. produces continuous positive airway pressure. It measures low and high pressures and advises the user if the pressure fall outside the user-set ranges. It operates on AC / DC power and provides digital and graphically readouts of the pressure - real-time and peak pressures. It connects into the patient circuit with the use of a pressure tubing with integral in-line filter and a connector.
Ask a Question
K Number
K982283Device Name
WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH
Manufacturer
CARADYNE, LTD.
Date Cleared
1999-03-09
(252 days)
Product Code
BYE
Regulation Number
868.5965Why did this record match?
Applicant Name (Manufacturer) :
CARADYNE, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To provide CPAP to spontaneously breathing patients in the hospital and pre-hospital (EMS) environment.
Device Description
The Whisperflow Oxygen Flow Generator is a venturi type oxygen / air mixture delivery device which provides CPAP pressure at high flows to a spontaneously breathing patient. It can deliver up to 140 Lpm flow at a FiO2 between 28- 100%. It utilizes standard in-line PEEP valves to set the prescribed pressure and interfaces with the patient via a face mask or ET tube.
Ask a Question
Page 1 of 1