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510(k) K930575

Device
KAMPPETER ANOMALOSCOPE
Applicant
BOVA INTL.
510(k) number
K930575
Product code
HIW  
Decision
Substantially Equivalent (SESE)
Decision date
1994-02-25
Date received
1993-02-04
Regulation
886.1070
Classification name
Anomaloscope
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
BODO OEHLER
Address
2217 Sixth Ave. Fort Worth TX US 76116 76116

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HIW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K913962ANOMALOSCOPE QUADRANT TEST-6Lkc Technologies, Inc.1991-10-23
K860174GUNKEL CHROMAGRAPH COLOR VISION TESTERChromagraphics, Inc.1986-04-04

Legacy Summary#

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FDA Review#

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