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510(k) K963762

Device
CORNEAL TOPOGRAPHER 200
Applicant
ECLIPSE VENTURES
510(k) number
K963762
Product code
MMQ  
Decision
Substantially Equivalent (SESE)
Decision date
1996-12-23
Date received
1996-09-19
Regulation
886.1350
Classification name
Topographer, Corneal, Ac-powered
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
RICHARD G HUNTER
Address
108 Sayre Dr. Princeton NJ US 08540 08540

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MMQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K981665SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICEBio-Medical Sciences, Inc.1998-12-07
K964702EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800Euclid Systems Corp.1997-05-20
K964891ORBSHOT KERATOMETEROrbtek, Inc.1997-03-26
K950077INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS)Par Vision Systems Corp.1995-06-14

Legacy Summary#

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FDA Review#

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