Cleared Traditional

KEELER TEARSCOPE-PLUS

K973064 · Keeler Instruments, Inc. · Ophthalmic
Apr 1998
Decision
232d
Days
Class 2
Risk

About This 510(k) Submission

K973064 is an FDA 510(k) clearance for the KEELER TEARSCOPE-PLUS, a Biomicroscope, Slit-lamp, Ac-powered (Class II — Special Controls, product code HJO), submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on April 7, 1998, 232 days after receiving the submission on August 18, 1997. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number K973064 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 1997
Decision Date April 07, 1998
Days to Decision 232 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HJO — Biomicroscope, Slit-lamp, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1850

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