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FDA 510(k)

CHROMOPHARE E 668

K-Number: K090378 · 2009-02-23

ApplicantBerchtold GmbH & Co. KG
Decision Date2009-02-23
Product CodeFSY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CHROMOPHARE E 668 is the device name listed in this FDA 510(k) record. The listed applicant is Berchtold GmbH & Co. KG. It received FDA 510(k) clearance on 2009-02-23 under 510(k) number K090378. 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 CHROMOPHARE E 668?

CHROMOPHARE E 668 is a medical device that received FDA 510(k) clearance on 2009-02-23. The listed applicant is Berchtold GmbH & Co. KG. The 510(k) number is K090378.

When did CHROMOPHARE E 668 receive FDA 510(k) clearance?

CHROMOPHARE E 668 received FDA 510(k) clearance on 2009-02-23, under 510(k) number K090378.

Who is the listed applicant for CHROMOPHARE E 668?

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

What is the FDA product code for CHROMOPHARE E 668?

The FDA product code for CHROMOPHARE E 668 is FSY.

Related Clinical Trials

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.

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Other records listing Berchtold 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.

K120392CHROMOPHARE F 628 AND F 528

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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