Cleared Traditional

OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS

K093495 · American Diagnostic Corp. · Ophthalmic
Nov 2010
Decision
374d
Days
Class 2
Risk

About This 510(k) Submission

K093495 is an FDA 510(k) clearance for the OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS, a Ophthalmoscope, Battery-powered (Class II — Special Controls, product code HLJ), submitted by American Diagnostic Corp. (Hauppauge, US). The FDA issued a Cleared decision on November 19, 2010, 374 days after receiving the submission on November 10, 2009. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number K093495 FDA.gov
FDA Decision Cleared SESE
Date Received November 10, 2009
Decision Date November 19, 2010
Days to Decision 374 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

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

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