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FDA 510(k)

AURORA LED SERIES SURGICAL LIGHTS

K-Number: K071698 · 2007-07-06

ApplicantSkytron, Div. the Kmw Group, Inc.
Decision Date2007-07-06
Product CodeFSY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AURORA LED SERIES SURGICAL LIGHTS is the device name listed in this FDA 510(k) record. The listed applicant is Skytron, Div. the Kmw Group, Inc.. It received FDA 510(k) clearance on 2007-07-06 under 510(k) number K071698. 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 AURORA LED SERIES SURGICAL LIGHTS?

AURORA LED SERIES SURGICAL LIGHTS is a medical device that received FDA 510(k) clearance on 2007-07-06. The listed applicant is Skytron, Div. the Kmw Group, Inc.. The 510(k) number is K071698.

When did AURORA LED SERIES SURGICAL LIGHTS receive FDA 510(k) clearance?

AURORA LED SERIES SURGICAL LIGHTS received FDA 510(k) clearance on 2007-07-06, under 510(k) number K071698.

Who is the listed applicant for AURORA LED SERIES SURGICAL LIGHTS?

The FDA 510(k) record lists Skytron, Div. the Kmw Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AURORA LED SERIES SURGICAL LIGHTS?

The FDA product code for AURORA LED SERIES SURGICAL LIGHTS is FSY.

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Other records listing Skytron, Div. the Kmw Group, Inc. 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.

K021585STELLAR SERIES SURGICAL LIGHTS WITH HERMESK002463STELLARK992090MILLENNIUM GOLDK950192SKYTRON SKYBOOM SERIESK940616SKYTRON ELITE 3500 TABLEK933564SKYTRON EXAM LIGHT

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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 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

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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