FDA.reportPublic FDA data

510(k) K842128

Device
AMERICAN MEDICAL OPTICS PHOTOKERATO
Applicant
AMERICAN MEDICAL OPTICS
510(k) number
K842128
Product code
HJA  
Decision
Substantially Equivalent (SESE)
Decision date
1984-08-07
Date received
1984-05-29
Regulation
886.1350
Classification name
Photokeratoscope
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HJA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K901523VKG 1000, VIDEO KERATOGRAPHThe Sanborn Co.1990-06-27
K893968VKG 2000 VIDEO KERATOMETERTechnitex, Inc.1989-09-11
K830290DORC CONTACT/PHOTO DERATOSCOPEJedmed Instrument Co.1983-03-09
K781650TERRY KERATOMETERClifford M. Terry, M.C.1978-10-17

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