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510(k) Data Aggregation
K Number
K990960Device Name
PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040)
Manufacturer
PERIMED, INC.
Date Cleared
1999-09-23
(185 days)
Product Code
LKD, DAT
Regulation Number
868.2480Why did this record match?
Applicant Name (Manufacturer) :
PERIMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
When installed in the Periflux System 5000, the Transcutaneous PO₂ and PCO₂ Monitor (PF5040) is intended to monitor the levels of oxygen and/or carbon dioxide from tissue transcutaneously. The unit provides continuous, non-invasive monitoring of cutaneous oxygen and carbon dioxide.
The Periflux System 5000 with the pO₂/pCO₂ module is intended to be used in hospitals and facility offices. It is intended to monitor transcutaneous pCO₂ in adults and pO₂ in infants not under gas anesthesia. The system is not intended for use by patients without the supervision of a physician.
Device Description
The Transcutaneous PO₂ and PCO₂ Monitor (PF5040) is a modular unit which can be installed in the Periflux System 5000 transcutaneous monitoring system. Patient monitoring is accomplished by the application of an electrode to specific sites on the patient after calibration of the unit.
The Periflux System 5000 is a multi-channel, multi-function system capable of hosting several function units including: the Modular Laser Doppler system for blood perfusion and the Transcutaneous PO₂ and PCO₂ Monitor (PF5040) for monitoring oxygen and/or carbon dioxide levels. The Periflux system 5000 can accommodate up to four different function units enabling different types of simultaneous measurements.
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K Number
K974285Device Name
PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT
Manufacturer
PERIMED, INC.
Date Cleared
1998-05-28
(195 days)
Product Code
DPW
Regulation Number
870.2100Why did this record match?
Applicant Name (Manufacturer) :
PERIMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PeriFlux System 5000 is indicated for use in measuring microvascular perfusion, in skin and muscle, in humans. It is also indicated for use in measuring microvascular perfusion in all tissues in animals.
Device Description
The PeriFlux System 5000 Modular Laser Doppler Flowmeter System 5000 consists of a PF 5001 Main Unit, which can accommodate up to four Function Units. The first available Function Unit is the PF 5010 LDPM (Laser Doppler Perfusion Monitor) Unit. A PF 5990 Blank Panel takes the place of a Function Unit if less than four Units are required. Probes are attached to collect the information, which is analysed, using the PeriSoft analysis program.
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