CHROMOPHARE— 510(k) K944855

Name: FDA 510(k) clearance K944855
Creator: U.S. Food and Drug Administration
Published: 1994-10-19

Substantially Equivalent

Berchtold Holding GmbH

FDA 510(k) clearance K944855 for CHROMOPHARE, Substantially Equivalent on 1994-10-19. Applicant: Berchtold Holding GmbH. Device class: 2.

Clearance details

Applicant: Berchtold Holding GmbH
Product code: Code FSY
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 1994-09-30
Decision date: 1994-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuttlingen, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code FSY

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K142984 — Leo Minor2014-10-29
K142076 — CLAVEGUARD FREEDOM SURGICAL LIGHT2014-09-30
K140812 — MI-750 PROCEDURAL/MINOR SURGICAL LIGHT2014-08-07
K132551 — ZF 7202014-06-30
K140930 — VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES2014-06-09

More clearances from Berchtold Holding GmbH

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K083066 — CHROMOPHARE E 778 AND E 5582008-10-30
K080857 — CHROMOPHARE E-SERIES2008-04-10
K024132 — CHROMOPHARE X 652003-03-21
K990656 — CHROMOPHARE D 530 LDR SURGICAL LIGHT1999-07-20
K991527 — CHROMOPHARE D500, D530, D6501999-05-27

Adverse events under product code FSY

product code FSY

Malfunction: 2,759
Other: 1
Total: 2,760

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.