Cleared Traditional

VISTA STREAK RETINOSCOPE (AC-POWERED)

K893171 · Keeler Instruments, Inc. · Ophthalmic
Sep 1989
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K893171 is an FDA 510(k) clearance for the VISTA STREAK RETINOSCOPE (AC-POWERED), a Retinoscope, Ac-powered (Class II — Special Controls, product code HKL), submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on September 21, 1989, 149 days after receiving the submission on April 25, 1989. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1780.

Submission Details

510(k) Number K893171 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 1989
Decision Date September 21, 1989
Days to Decision 149 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HKL — Retinoscope, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1780