Cleared Traditional

TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER

K053430 · Medtronic Xomed, Inc. · Ophthalmic
Mar 2006
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K053430 is an FDA 510(k) clearance for the TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER, a Tonometer, Manual (Class II — Special Controls, product code HKY), submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on March 3, 2006, 84 days after receiving the submission on December 9, 2005. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number K053430 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 2005
Decision Date March 03, 2006
Days to Decision 84 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HKY — Tonometer, Manual
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1930

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