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510(k) K965130

CHROMOPHARE by Berchtold Holding GmbH — Product Code FSY

K965130 is an FDA 510(k) premarket notification submitted by Berchtold Holding GmbH for the device "CHROMOPHARE". The FDA issued a decision of Substantially Equivalent on July 14, 1997. 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
July 14, 1997
Date Received
December 23, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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

  • K083066 — CHROMOPHARE E 778 AND E 558 (October 30, 2008)
  • 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)
  • 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)
  • K140460 — MACH LED 2SC (April 3, 2014)
  • K140461 — MACH LED 2MC (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