Cleared Traditional

K022054 - F 900 (FDA 510(k) Clearance)

K022054 · C.S.O. S.R.L. · Ophthalmic device
Aug 2002
Decision
43d
Days
Class 2
Risk

K022054 is an FDA 510(k) clearance for the F 900. This device is classified as a Tonometer, Manual (Class II - Special Controls, product code HKY).

Submitted by C.S.O. S.R.L. (Williamsville, US). The FDA issued a Cleared decision on August 6, 2002, 43 days after receiving the submission on June 24, 2002.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number K022054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2002
Decision Date August 06, 2002
Days to Decision 43 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