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510(k) K083066

CHROMOPHARE E 778 AND E 558 by Berchtold Holding GmbH — Product Code FSY

K083066 is an FDA 510(k) premarket notification submitted by Berchtold Holding GmbH for the device "CHROMOPHARE E 778 AND E 558". The FDA issued a decision of Substantially Equivalent on October 30, 2008. The device falls under product code FSY (Light, Surgical, Ceiling Mounted), a Class II device regulated under 21 CFR 878.4580. Berchtold Holding GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2008
Date Received
October 15, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Light, Surgical, Ceiling Mounted
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Berchtold Holding GmbH

  • K080857 — CHROMOPHARE E-SERIES (April 10, 2008)
  • K024132 — CHROMOPHARE X 65 (March 21, 2003)
  • K990656 — CHROMOPHARE D 530 LDR SURGICAL LIGHT (July 20, 1999)
  • K991527 — CHROMOPHARE D500, D530, D650 (May 27, 1999)
  • K974433 — CHROMOPHARE D 500, CHROMOPHARE D 530 (February 20, 1998)
  • K965130 — CHROMOPHARE (July 14, 1997)
  • K955750 — TELETOM (February 8, 1996)
  • K950932 — BIPOLAP HOOK ELECTRODE (March 15, 1995)
  • K944855 — CHROMOPHARE (October 19, 1994)
  • K942319 — HIRSCH BIPOLAR COAGULATION FORCEPS AND ADAPTOR CABLES (June 8, 1994)

Other clearances for product code FSY

  • K142984 — Leo Minor (October 29, 2014)
  • K142076 — CLAVEGUARD FREEDOM SURGICAL LIGHT (September 30, 2014)
  • K140812 — MI-750 PROCEDURAL/MINOR SURGICAL LIGHT (August 7, 2014)
  • K132551 — ZF 720 (June 30, 2014)
  • K140930 — VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES (June 9, 2014)
  • K140461 — MACH LED 2MC (April 3, 2014)
  • K140460 — MACH LED 2SC (April 3, 2014)
  • K132747 — VISUM BLADE LED SURGICAL LIGHTING SYSTEM (December 30, 2013)
  • K132307 — VIDA LED SURGICAL LIGHTING SYSTEM (November 5, 2013)
  • K131893 — AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS (October 30, 2013)

FDA data resources