Cleared Traditional

KEELER DUAL LIGHTSOURCE

K861746 · Keeler Instruments, Inc. · Ophthalmic
Aug 1986
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K861746 is an FDA 510(k) clearance for the KEELER DUAL LIGHTSOURCE, a Headlamp, Operating, Ac-powered (Class II — Special Controls, product code HPQ), submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on August 21, 1986, 107 days after receiving the submission on May 6, 1986. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4335.

Submission Details

510(k) Number K861746 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 1986
Decision Date August 21, 1986
Days to Decision 107 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HPQ — Headlamp, Operating, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4335