Cleared Traditional

SURGICAL IOP MONITOR

K832996 · Miami Eye Technology, Inc. · Ophthalmic
Nov 1983
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K832996 is an FDA 510(k) clearance for the SURGICAL IOP MONITOR, a Tonometer, Manual (Class II — Special Controls, product code HKY), submitted by Miami Eye Technology, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 28, 1983, 87 days after receiving the submission on September 2, 1983. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number K832996 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 1983
Decision Date November 28, 1983
Days to Decision 87 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

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