Cleared Special

VANTAGE INDIRECT OPHTHALMOSCOPE

K060822 · Keeler Instruments, Inc. · Ophthalmic
May 2006
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K060822 is an FDA 510(k) clearance for the VANTAGE INDIRECT OPHTHALMOSCOPE, 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 May 23, 2006, 57 days after receiving the submission on March 27, 2006. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number K060822 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 2006
Decision Date May 23, 2006
Days to Decision 57 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

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

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