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510(k) K802351

Device
F110 PHOTO BINOCULAR OPHTHALMOSCOPE
Applicant
MINAMI, TOMINE & LEW
510(k) number
K802351
Product code
HLG  
Decision
Substantially Equivalent (SESE)
Decision date
1980-12-17
Date received
1980-09-25
Regulation
886.1700
Classification name
Pupillometer, Ac-powered
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HLG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K920937COMPUTERIZED PUPILTrek Medical Products, Inc.1992-10-02
K895609PUPIL PATHWAY ANALYZER (PPA)Pulse Medical Instruments1989-11-02

Legacy Summary#

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FDA Review#

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