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510(k) K872111

Device
ORTHOTONE
Applicant
ORTHOTONE CORP.
510(k) number
K872111
Product code
HLL  
Decision
Substantially Equivalent (SESE)
Decision date
1988-11-16
Date received
1987-06-01
Regulation
886.1510
Classification name
Monitor, Eye Movement
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOHN ORZUCHOWSKI
Address
201 E. 28th St., Suite 6-F New York NY US 10016 10016

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HLL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K222484RetitrackC. Light Technologies, Inc.2023-05-09
K152890SACCADOMETER PLUS, SACCADOMETER ADVANCEDOber Consulting Sp. Z.O.O.2016-08-11
K033949VARILUX VISIONPRINT SYSTEM (VPS)Essilor Intl.2004-07-02

Legacy Summary#

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FDA Review#

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