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FDA 510(k)

CHROMOPHARE F 628 AND F 528

K-Number: K120392 · 2012-02-16

ApplicantBerchtold GmbH & Co. KG
Decision Date2012-02-16
Product CodeFSY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CHROMOPHARE F 628 AND F 528 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 2012-02-16 under 510(k) number K120392. 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 F 628 AND F 528?

CHROMOPHARE F 628 AND F 528 is a medical device that received FDA 510(k) clearance on 2012-02-16. The listed applicant is Berchtold GmbH & Co. KG. The 510(k) number is K120392.

When did CHROMOPHARE F 628 AND F 528 receive FDA 510(k) clearance?

CHROMOPHARE F 628 AND F 528 received FDA 510(k) clearance on 2012-02-16, under 510(k) number K120392.

Who is the listed applicant for CHROMOPHARE F 628 AND F 528?

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 F 628 AND F 528?

The FDA product code for CHROMOPHARE F 628 AND F 528 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.

K090378CHROMOPHARE E 668

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.K102758TRULIGHT 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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