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510(k) Data Aggregation
K Number
K023245Device Name
BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01
Manufacturer
PARADIGM MEDICAL INDUSTRIES, INC.
Date Cleared
2002-10-21
(21 days)
Product Code
NJJ
Regulation Number
886.1930Why did this record match?
Product Code :
NJJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tonometry for Measuring and Recording Intraocular Pressures and Intraocular Pressure Pulse Amplitudes, Pulsatile Ocular Blood Flow, Pulsatile Ocular Blood Volume, Pulsatility Index Equivalent (PEQ).
Device Description
The Paradigm Medical Industries, Inc. Blood Flow Analyzer (BFA) is an electronic pneumatic tonometer capable of measuring and recording the intraocular pressure. The pressure measurements are made at a rate of 200 times per second over a period of 5-15 seconds. Contact with the eye is by means of a sterilized single-use per patient probe having an integral membrane that isolates the cornea from the internal pneumatic operation of the BFA. The pulsatile ocular blood flow is derived from the intraocular pressure measurements acquired with the pneumatic tonometer using mathematical equations that link intraocular pressure to ocular volume change and volume flow.
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