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510(k) K922836

CHROMOPHARE by Berchtold Holding GmbH — Product Code FSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 1992
Date Received
June 12, 1992
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)
  • K965130 — CHROMOPHARE (July 14, 1997)
  • K955750 — TELETOM (February 8, 1996)
  • K950932 — BIPOLAP HOOK ELECTRODE (March 15, 1995)
  • K944855 — CHROMOPHARE (October 19, 1994)

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  • K140461 — MACH LED 2MC (April 3, 2014)
  • K140460 — MACH LED 2SC (April 3, 2014)
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  • K132307 — VIDA LED SURGICAL LIGHTING SYSTEM (November 5, 2013)
  • K131893 — AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS (October 30, 2013)