Cleared Traditional

KEELER KONAN SPECULAR MICROSCOPE SP3300

K900111 · Keeler Instruments, Inc. · Ophthalmic
Mar 1990
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K900111 is an FDA 510(k) clearance for the KEELER KONAN SPECULAR MICROSCOPE SP3300, a Ophthalmoscope, Ac-powered (Class II — Special Controls, product code HLI), submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on March 23, 1990, 73 days after receiving the submission on January 9, 1990. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number K900111 FDA.gov
FDA Decision Cleared SESE
Date Received January 09, 1990
Decision Date March 23, 1990
Days to Decision 73 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HLI — Ophthalmoscope, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1570

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