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510(k) K936205

Device
COMPREHENSIVE PHOROPTER, MDR-680
Applicant
CANON U.S.A., INC.
510(k) number
K936205
Product code
HKN  
Decision
Substantially Equivalent (SESE)
Decision date
1994-09-28
Date received
1993-12-29
Regulation
886.1770
Classification name
Refractor, Manual, Non-powered, Including Phoropter
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
KOICHI YANO
Address
One Canon Plz. Lake Success NY US 11042 11042

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HKN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K874900WOODLYN CLASSIC REFRACTOR, PHOROPTORWoodlyn, Inc.1987-12-23
K782118FUL-VUEAmerican Optical Corp.1979-01-26

Legacy Summary#

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FDA Review#

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