Cleared Traditional

K832073 - ELECTRIC INSTRUMENT TABLE (FDA 510(k) Clearance)

Aug 1983
Decision
45d
Days
Class 1
Risk

K832073 is an FDA 510(k) clearance for the ELECTRIC INSTRUMENT TABLE. This device is classified as a Stand, Instrument, Ac-powered, Ophthalmic (Class I - General Controls, product code HMF).

Submitted by CooperVision, Inc. (Walker, US). The FDA issued a Cleared decision on August 12, 1983, 45 days after receiving the submission on June 28, 1983.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1860.

Submission Details

510(k) Number K832073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1983
Decision Date August 12, 1983
Days to Decision 45 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary

Device Classification

Product Code HMF — Stand, Instrument, Ac-powered, Ophthalmic
Device Class Class I - General Controls
CFR Regulation 21 CFR 886.1860