Cleared Traditional

VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED)

K893172 · Keeler Instruments, Inc. · Ophthalmic
Jun 1989
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K893172 is an FDA 510(k) clearance for the VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED), 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 June 5, 1989, 41 days after receiving the submission on April 25, 1989. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number K893172 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 1989
Decision Date June 05, 1989
Days to Decision 41 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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