Meddev Multarray (TM) Medical Examination Light

FDA 510(k) K931197 · Meddev International Corp.

Substantially Equivalent

510(k) numberK931197

Submission

Device name
Meddev Multarray (TM) Medical Examination Light
Applicant
Meddev International Corp.
Los Altos, CA, US
Received
March 9, 1993
Decision date
September 23, 1993
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

Other 510(k)s with product code KZF

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K954943NevoscopeKZF · Traditional Nizar A. Mullani03/27/1996SE
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K945507H 5100, H 5200, H 5300KZF · Traditional Rudolf Riester GmbH & Co. KG12/09/1994SE
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
K940284Meddev Multarray Medical Examining Light ModificationKZF · Traditional Meddev International Corp.02/28/1994SE
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

More from Midmark Corp.

510(k)DeviceDecision
K940284Meddev Multarray Medical Examining Light ModificationKZF · Traditional 02/28/1994SE
K874562SecuratrodeDRX · Traditional 01/28/1988SE
K771435Urinary Leg Bag, SteoileKNX · Traditional 09/20/1977SE

Questions and answers

When was Meddev Multarray (TM) Medical Examination Light cleared by the FDA?

Meddev Multarray (TM) Medical Examination Light (K931197) received a 510(k) decision of Substantially Equivalent on September 23, 1993, 198 days after the submission was received.

What is the product code of K931197?

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