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510(k) Data Aggregation
K Number
K962532Device Name
RODENSTOCK SLITLAMP (MODEL 5000 & 4000)
Manufacturer
Date Cleared
1996-07-25
(27 days)
Product Code
Regulation Number
886.1850Why did this record match?
Applicant Name (Manufacturer) :
EXPERTECH ASSOC., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device and accessories are indicated as a noninvasive aid in the examination and diagnosis of eye conditions and in the fitting of contact lenses. The indications are the same as those claimed for the predicate devices.
Device Description
The Rodenstock brand RO 5000 and RO 4000 slitlamps are instruments used for eye examination and the fitting of contact lenses. Each device consists of a microscope combined with a light source that can be narrowed into a slit for illumination of the eye. Each is available with accessories to measure characteristics of the eye and to document actual shapes. The device is powered by 6.3 to 12v AC and 50-60 Hz.
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