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510(k) Data Aggregation
K Number
K151491Device Name
Falck Medical Multifunction Tonometer, FAT1
Manufacturer
Date Cleared
2016-01-15
(226 days)
Regulation Number
886.1930Why did this record match?
Applicant Name (Manufacturer) :
FALCK MEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Falck Medical Multi-function Tonometer (FAT1) is indicated for the measurement of intraocular pressure, ocular pulsatile amplitude, force (Ophthalmodynamometry) and estimating conventional outflow facility with calibrated force application (Indentation Tonography).
Device Description
The Falck Medical Multi-function Tonometer (FAT1) mounts on the slit lamp microscope. The device has a floating prism arm which holds a disposable plastic prism. The device has a detection system located in the prism arm head that prevents re-use of the prism.
The prism optical system uses the principle of total internal reflectance. Sampling is every 7 milliseconds and multiple samples are obtained for each measurement. Each measurement is statistically analyzed for repeatability and accuracy. Intraocular pressure is measured using the Imbert-Fick method of applanation. Force application is controlled by the microprocessor. The ocular pulsatile amplitude and central retinal artery pulsation with force application is optically captured. Indentation tonography methodology using calibrated force application is used to measure conventional outflow facility.
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