Cleared Traditional

HI-LO FLOOR STANDING EXAM. LIGHT

K842135 · Good-Lite Co. · General Hospital

Jul 1984

Decision

37d

Days

Class 1

Risk

About This 510(k) Submission

K842135 is an FDA 510(k) clearance for the HI-LO FLOOR STANDING EXAM. LIGHT, a Device, Medical Examination, Ac Powered (Class I — General Controls, product code KZF), submitted by Good-Lite Co. (Mchenry, US). The FDA issued a Cleared decision on July 6, 1984, 37 days after receiving the submission on May 30, 1984. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6320.

Submission Details

510(k) Number	K842135 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 30, 1984
Decision Date	July 06, 1984
Days to Decision	37 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—