Cleared Traditional

K873908 - H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK.
(FDA 510(k) Clearance)

K873908 · Richmond Products, Inc. · Ophthalmic
Dec 1987
Decision
89d
Days
Class 1
Risk

K873908 is an FDA 510(k) clearance for the H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK., a Tester, Color Vision (Class I — General Controls, product code HIT), submitted by Richmond Products, Inc. (Boca Raton, US). The FDA issued a Cleared decision on December 23, 1987, 89 days after receiving the submission on September 25, 1987. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1170.

Submission Details

510(k) Number K873908 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 1987
Decision Date December 23, 1987
Days to Decision 89 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary

Device Classification

Product Code HIT — Tester, Color Vision
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1170