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510(k) K842892

Device
NIDEK DIGITAL KERATOMETER
Applicant
NIDEK, INC.
510(k) number
K842892
Product code
HQL  
Decision
Substantially Equivalent (SESE)
Decision date
1984-10-05
Date received
1984-07-23
Regulation
886.3600
Classification name
Intraocular Lens
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
3
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 HQL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K914311CHIROFLEX II LENS MICROSERT(TM)Chiron Ophthalmics1992-01-27
K913626SOFTRANS INJECTORStaar Surgical Co.1991-12-18
K842504AMER. MEDICAL OPTICS DIGITAL KERATO-American Medical Optics1984-10-01
K771933CILCO ANTERIOR CHAMBER LENSCalifornia Intraocular Lens1978-01-26

Legacy Summary#

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FDA Review#

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