FDA.reportPublic FDA data

510(k) K964891

Device
ORBSHOT KERATOMETER
Applicant
ORBTEK, INC.
510(k) number
K964891
Product code
MMQ  
Decision
Substantially Equivalent (SESE)
Decision date
1997-03-26
Date received
1996-12-06
Regulation
886.1350
Classification name
Topographer, Corneal, Ac-powered
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
PIER CALACINO
Address
3030 S. Main St. Suite 600 Salt Lake City UT US 84115 84115

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
K963762CORNEAL TOPOGRAPHER 200Eclipse Ventures1996-12-23
K950077INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS)Par Vision Systems Corp.1995-06-14

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases