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510(k) K823385

Device
ALES
Applicant
OMS
510(k) number
K823385
Product code
HPG  
Decision
Substantially Equivalent (SESE)
Decision date
1983-03-09
Date received
1982-11-15
Regulation
886.5900
Classification name
Aid, Vision, Electronic, Battery-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 HPG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K910601PATHFINDERNurion Industries1991-05-14
K910124LOW VISION ENHANCEMENT SYSTEM (LVES)Triangle Investments1991-04-10
K903558LASER CANENurion Industries1990-09-27
K902187POLARONNurion Industries1990-08-08
K862338SENSORY 6Brytech, Inc.1986-09-03
K761215F4912 NIGHT VISION AIDItt Corp.1976-12-16

Legacy Summary#

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FDA Review#

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