Hi-Lo Floor Standing Exam. Light

FDA 510(k) K842135 · Good-Lite Co.

Substantially Equivalent

510(k) numberK842135

Submission

Device name
Hi-Lo Floor Standing Exam. Light
Applicant
Good-Lite Co.
Mchenry, IL, US
Received
May 30, 1984
Decision date
July 6, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KZF – Device, Medical Examination, Ac Powered
Device class
Class I (low risk)
Regulation
21 CFR 880.6320
Specialty
General Hospital

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K940284Meddev Multarray Medical Examining Light ModificationKZF · Traditional Meddev International Corp.02/28/1994SE
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K935832ChromophareKZF · Traditional Berchtold Holding GmbH02/03/1994SE
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More from Midmark Corp.

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Questions and answers

When was Hi-Lo Floor Standing Exam. Light cleared by the FDA?

Hi-Lo Floor Standing Exam. Light (K842135) received a 510(k) decision of Substantially Equivalent on July 6, 1984, 37 days after the submission was received.

What is the product code of K842135?

The FDA product code is KZF – Device, Medical Examination, Ac Powered, a Class I (low risk) device regulated under 21 CFR 880.6320.