Cleared Traditional

ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC)

K861013 · Ameritek, Inc. · Ophthalmic
Mar 1986
Decision
13d
Days
Class 1
Risk

About This 510(k) Submission

K861013 is an FDA 510(k) clearance for the ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC), a Device, Irrigation, Ocular Surgery (Class I — General Controls, product code KYG), submitted by Ameritek, Inc. (Miami, US). The FDA issued a Cleared decision on March 31, 1986, 13 days after receiving the submission on March 18, 1986. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4360.

Submission Details

510(k) Number K861013 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 1986
Decision Date March 31, 1986
Days to Decision 13 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code KYG — Device, Irrigation, Ocular Surgery
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4360

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