Cleared Traditional

K844362 - OPHTHALMIC CHAIR
(FDA 510(k) Clearance)

K844362 · Luneau Laboratories · Ophthalmic

Dec 1984

Decision

28d

Days

Class 1

Risk

K844362 is an FDA 510(k) clearance for the OPHTHALMIC CHAIR. This device is classified as a Stand, Instrument, Ac-powered, Ophthalmic (Class I — General Controls, product code HMF).

Submitted by Luneau Laboratories (Washington, US). The FDA issued a Cleared decision on December 11, 1984, 28 days after receiving the submission on November 13, 1984.

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

Submission Details

510(k) Number	K844362 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 13, 1984
Decision Date	December 11, 1984
Days to Decision	28 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—