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510(k) Data Aggregation
K Number
K040325Device Name
PANORET, MODEL PNM 60
Manufacturer
Date Cleared
2004-03-08
(27 days)
Product Code
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
MEDIBELL MEDICAL VISION TECHNOLOGIES LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PNM 60 is a diagnostic device indicated to provide digital photographs of the interior of the eye as well as the anterior segment and external part of the eye.
Device Description
The PNM 60 is a modification of the legally marketed Panoret 1000 A K001111 Digital Retinoscope. It is based on transcleral illumination. Its optics distinguishes the illumination path from the imaging path, thus, enables non mydriatic wide angle imaging. The Panoret viewing angle has been changed from (Panoret 1000A) 100 degrees to PNM 60 degrees
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