Meddev Multarray Medical Examining Light Modification

FDA 510(k) K940284 · Meddev International Corp.

Substantially Equivalent

510(k) numberK940284

Submission

Device name
Meddev Multarray Medical Examining Light Modification
Applicant
Meddev International Corp.
Los Altos, CA, US
Received
January 4, 1994
Decision date
February 28, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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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K941869Splint, Pneumatic, Arm & Splint, Pneumatic, LegKZF · Traditional The Lighthouse For the Blind, Inc.08/03/1994SE
K936088Wave Fluorescent MagnifierKZF · Traditional Burton Medical Products Corp.04/26/1994SE
K933564Skytron Exam LightKZF · Traditional Skytron, Div. the Kmw Group, Inc.02/10/1994SE
K935832ChromophareKZF · Traditional Berchtold Holding GmbH02/03/1994SE
K934259Ac-Powered Medical Examination LightKZF · Traditional Welch Allyn, Inc.01/28/1994SE
K932719Ritter Model 158 and 159 Exam LightsKZF · Traditional Midmark Corp.12/02/1993SE
K924447VitapenKZF · Traditional Vitajet Corp.09/27/1993SE

More from Vitajet Corp.

510(k)DeviceDecision
K931197Meddev Multarray (TM) Medical Examination LightKZF · Traditional 09/23/1993SE
K874562SecuratrodeDRX · Traditional 01/28/1988SE
K771435Urinary Leg Bag, SteoileKNX · Traditional 09/20/1977SE

Questions and answers

When was Meddev Multarray Medical Examining Light Modification cleared by the FDA?

Meddev Multarray Medical Examining Light Modification (K940284) received a 510(k) decision of Substantially Equivalent on February 28, 1994, 55 days after the submission was received.

What is the product code of K940284?

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