Cleared Traditional

MACHEMER/TANO ROTATING

K833820 · Optical Micro Systems, Inc. · Ophthalmic
Jan 1984
Decision
63d
Days
Class 1
Risk

About This 510(k) Submission

K833820 is an FDA 510(k) clearance for the MACHEMER/TANO ROTATING, a Table, Instrument, Powered, Ophthalmic (Class I — General Controls, product code HRJ), submitted by Optical Micro Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 4, 1984, 63 days after receiving the submission on November 2, 1983. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4855.

Submission Details

510(k) Number K833820 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 1983
Decision Date January 04, 1984
Days to Decision 63 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HRJ — Table, Instrument, Powered, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4855