Cleared Traditional

TONOSHIELD TONOMETER SHIELD

K923877 · Oasis Medical, Inc. · Ophthalmic
Sep 1992
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K923877 is an FDA 510(k) clearance for the TONOSHIELD TONOMETER SHIELD, a Tonometer, Manual (Class II — Special Controls, product code HKY), submitted by Oasis Medical, Inc. (Glendora, US). The FDA issued a Cleared decision on September 30, 1992, 58 days after receiving the submission on August 3, 1992. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number K923877 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 1992
Decision Date September 30, 1992
Days to Decision 58 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

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