Chromophare X 65

FDA 510(k) K024132 · Berchtold Holding GmbH

Substantially Equivalent

510(k) numberK024132

Submission

Device name
Chromophare X 65
Applicant
Berchtold Holding GmbH
Tuttlingen, DE
Received
December 16, 2002
Decision date
March 21, 2003
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FSY – Light, Surgical, Ceiling Mounted
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4580
Specialty
General, Plastic Surgery

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Questions and answers

When was Chromophare X 65 cleared by the FDA?

Chromophare X 65 (K024132) received a 510(k) decision of Substantially Equivalent on March 21, 2003, 95 days after the submission was received.

What is the product code of K024132?

The FDA product code is FSY – Light, Surgical, Ceiling Mounted, a Class II (moderate risk) device regulated under 21 CFR 878.4580.