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510(k) K935832

CHROMOPHARE by Berchtold Holding GmbH — Product Code KZF

K935832 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 February 3, 1994. The device falls under product code KZF (Device, Medical Examination, Ac Powered), a Class I device regulated under 21 CFR 880.6320. Berchtold Holding GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1994
Date Received
December 7, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Medical Examination, Ac Powered
Device Class
Class I
Regulation Number
880.6320
Review Panel
HO
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)

Other clearances for product code KZF

  • K954943 — NEVOSCOPE (March 27, 1996)
  • K952835 — WELCH ALLYN VIDEO EPISCOPE (September 22, 1995)
  • K945507 — H 5100, H 5200, H 5300 (December 9, 1994)
  • K941869 — SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEG (August 3, 1994)
  • K936088 — WAVE FLUORESCENT MAGNIFIER (April 26, 1994)
  • K940284 — MEDDEV MULTARRAY MEDICAL EXAMINING LIGHT MODIFICATION (February 28, 1994)
  • K933564 — SKYTRON EXAM LIGHT (February 10, 1994)
  • K934259 — AC-POWERED MEDICAL EXAMINATION LIGHT (January 28, 1994)
  • K932719 — RITTER MODEL 158 AND 159 EXAM LIGHTS (December 2, 1993)
  • K924447 — VITAPEN (September 27, 1993)

FDA data resources