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510(k) Data Aggregation
K Number
K042099Device Name
TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH)
Manufacturer
Date Cleared
2004-12-10
(128 days)
Product Code
Regulation Number
886.1930Why did this record match?
Applicant Name (Manufacturer) :
RETINAPHARMA TECHNOLOGIES INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TonoPach Ultrasonic Tonometer/Pachymeter Model P-201 is a diagnostic instrument that is intended for use in the measurement of both intraocular pressure and corneal thickness. It is intended for use during or following surgery and as a screening, monitoring or diagnostic aid in patients with normal, disease-induced or surgically altered anatomy, or in glaucoma suspects under current therapeutic guidelines.
Device Description
The TonoPach is a portable, battery operated, handheld ophthalmic instrument which measures both intraocular pressure (IOP) and corneal thickness (CT) simultaneously and at the same locus on the cornea. The device uses the principles of applanation pneumatometery to measure IOP and the principles of reflection pulsed ultrasound pachymetry to measure CT. The system is comprised of the TonoPach electronics, transducer handpiece, protective membranes and optionally, a foot pedal.
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