510(k) K860174
- Device
- Gunkel Chromagraph Color Vision Tester
- Applicant
- CHROMAGRAPHICS, INC.
- 510(k) number
- K860174
- Product code
- HIW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-04-04
- Date received
- 1986-01-17
- Regulation
- 886.1070
- Classification name
- Anomaloscope
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RALPH D GUNKEL,O.D.
- Address
- 120 Center Dr. Apt. 709 Bethesda MD US 20814 20814
FDA Registration Numbers#
- 9611269
- 3033566
- 3020723591
- 3003951061
- 8043512
Source Documents#
510(k) summary PDF not indicated by FDA