Home / 510(k) Clearances / K990656

510(k) K990656

CHROMOPHARE D 530 LDR SURGICAL LIGHT by Berchtold Holding GmbH — Product Code FSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1999
Date Received
March 1, 1999
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)
  • 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)