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FDA 510(k)

AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS

K-Number: K131893 · 2013-10-30

ApplicantAjw Technology Consultants, Inc.
Decision Date2013-10-30
Product CodeFSY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS is the device name listed in this FDA 510(k) record. The listed applicant is Ajw Technology Consultants, Inc.. It received FDA 510(k) clearance on 2013-10-30 under 510(k) number K131893. 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 AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS?

AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS is a medical device that received FDA 510(k) clearance on 2013-10-30. The listed applicant is Ajw Technology Consultants, Inc.. The 510(k) number is K131893.

When did AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS receive FDA 510(k) clearance?

AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS received FDA 510(k) clearance on 2013-10-30, under 510(k) number K131893.

Who is the listed applicant for AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS?

The FDA 510(k) record lists Ajw Technology Consultants, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS?

The FDA product code for AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS is FSY.

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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 CorporationK122875ORICARE L2700Oricare, Inc.K120392CHROMOPHARE F 628 AND F 528Berchtold GmbH & Co. KGK102758TRULIGHT 5520 AND TRULIGHT 5320Trumpf Kreuzer Medizin Systeme GmbH + Co.KgK101537AIM 200, MAJOR SURGICAL LIGHTBurton Medical Products Corp.

Official Source

View on FDA Database →

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

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