Cleared Traditional

SURGICAL IOP MONITOR

K863235 · Ameritek, Inc. · Ophthalmic
Sep 1986
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K863235 is an FDA 510(k) clearance for the SURGICAL IOP MONITOR, a Tonometer, Ac-powered (Class II — Special Controls, product code HKX), submitted by Ameritek, Inc. (Seattle, US). The FDA issued a Cleared decision on September 25, 1986, 35 days after receiving the submission on August 21, 1986. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number K863235 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 1986
Decision Date September 25, 1986
Days to Decision 35 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HKX — Tonometer, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1930

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