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FDA 510(k)

CHROMOPHARE E-SERIES

K-Number: K080857 · 2008-04-10

ApplicantBerchtold Holding GmbH
Decision Date2008-04-10
Product CodeFSY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CHROMOPHARE E-SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Berchtold Holding GmbH. It received FDA 510(k) clearance on 2008-04-10 under 510(k) number K080857. 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-SERIES?

CHROMOPHARE E-SERIES is a medical device that received FDA 510(k) clearance on 2008-04-10. The listed applicant is Berchtold Holding GmbH. The 510(k) number is K080857.

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

CHROMOPHARE E-SERIES received FDA 510(k) clearance on 2008-04-10, under 510(k) number K080857.

Who is the listed applicant for CHROMOPHARE E-SERIES?

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

What is the FDA product code for CHROMOPHARE E-SERIES?

The FDA product code for CHROMOPHARE E-SERIES is FSY.

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Other records listing Berchtold Holding GmbH 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.

K083066CHROMOPHARE E 778 AND E 558K024132CHROMOPHARE X 65K990656CHROMOPHARE D 530 LDR SURGICAL LIGHTK991527CHROMOPHARE D500, D530, D650K974433CHROMOPHARE D 500, CHROMOPHARE D 530K965130CHROMOPHARE

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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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