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FDA 510(k)

MACH LED MC

K-Number: K093010 · 2010-04-01

ApplicantDr. Mach GmbH & Co. KG
Decision Date2010-04-01
Product CodeFSY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MACH LED MC is the device name listed in this FDA 510(k) record. The listed applicant is Dr. Mach GmbH & Co. KG. It received FDA 510(k) clearance on 2010-04-01 under 510(k) number K093010. The device is classified under product code FSY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MACH LED MC?

MACH LED MC is a medical device that received FDA 510(k) clearance on 2010-04-01. The listed applicant is Dr. Mach GmbH & Co. KG. The 510(k) number is K093010.

When did MACH LED MC receive FDA 510(k) clearance?

MACH LED MC received FDA 510(k) clearance on 2010-04-01, under 510(k) number K093010.

Who is the listed applicant for MACH LED MC?

The FDA 510(k) record lists Dr. Mach GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MACH LED MC?

The FDA product code for MACH LED MC is FSY.

Other records listing Dr. Mach GmbH & Co. KG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K093009MACH LED SC

Related Devices (Code: FSY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K132747VISUM BLADE LED SURGICAL LIGHTING SYSTEMStryker CommunicationsK132307VIDA LED SURGICAL LIGHTING SYSTEMConvida Healthcare & Systems CorporationK131893AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTSAjw Technology Consultants, Inc.K122875ORICARE L2700Oricare, Inc.K120392CHROMOPHARE F 628 AND F 528Berchtold GmbH & Co. KGK102758TRULIGHT 5520 AND TRULIGHT 5320Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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