510(k) K873908

H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK. by Richmond Products, Inc. — Product Code HIT

K873908 is an FDA 510(k) premarket notification submitted by Richmond Products, Inc. for the device "H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK.". The FDA issued a decision of Substantially Equivalent on December 23, 1987. The device falls under product code HIT (Tester, Color Vision), a Class I device regulated under 21 CFR 886.1170. Richmond Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1987
Date Received
September 25, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Color Vision
Device Class
Class I
Regulation Number
886.1170
Review Panel
OP
Submission Type