Mach LED MC

FDA 510(k) K093010 · Dr. Mach GmbH & Co. KG

Substantially Equivalent

510(k) numberK093010

Submission

Device name
Mach LED MC
Applicant
Dr. Mach GmbH & Co. KG
Ebersberg, DE
Received
September 29, 2009
Decision date
April 1, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FSY – Light, Surgical, Ceiling Mounted
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4580
Specialty
General, Plastic Surgery

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K140461Mach LED 2MCFSY · Special Dr. Mach GmbH & Co. KG04/03/2014SE
K140460Mach LED 2SCFSY · Special Dr. Mach GmbH & Co. KG04/03/2014SE
K132747Visum Blade LED Surgical Lighting SystemFSY · Traditional Stryker Communications12/30/2013SE
K132307Vida LED Surgical Lighting SystemFSY · Traditional Convida Healthcare & Systems Corporation11/05/2013SE
K131893Amico Ce Series Surgical Lights, Mira LED Series Minor Surgical LightsFSY · Traditional Ajw Technology Consultants, Inc.10/30/2013SE

More from Ajw Technology Consultants, Inc.

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K140461Mach LED 2MCFSY · Special 04/03/2014SE
K140460Mach LED 2SCFSY · Special 04/03/2014SE
K093009Mach LED SCFSY · Traditional 04/01/2010SE

Questions and answers

When was Mach LED MC cleared by the FDA?

Mach LED MC (K093010) received a 510(k) decision of Substantially Equivalent on April 1, 2010, 184 days after the submission was received.

What is the product code of K093010?

The FDA product code is FSY – Light, Surgical, Ceiling Mounted, a Class II (moderate risk) device regulated under 21 CFR 878.4580.