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510(k) K893808

MODEL 0450000, OPAL MEDICAL EXAM LIGHT by Burton Medical Products Corp. — Product Code KZF

K893808 is an FDA 510(k) premarket notification submitted by Burton Medical Products Corp. for the device "MODEL 0450000, OPAL MEDICAL EXAM LIGHT". The FDA issued a decision of Substantially Equivalent on August 15, 1989. The device falls under product code KZF (Device, Medical Examination, Ac Powered), a Class I device regulated under 21 CFR 880.6320. Burton Medical Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1989
Date Received
May 22, 1989
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 Burton Medical Products Corp.

  • K101537 — AIM 200, MAJOR SURGICAL LIGHT (September 30, 2010)
  • K042395 — OUTPATIENT III MINOR SURGERY LIGHT (December 1, 2004)
  • K000639 — VISIONARY 2000 (May 25, 2000)
  • K963682 — GENIE' SINGLE CEILING AND DOUBLE CEILING (November 13, 1996)
  • K961843 — GENIE (August 22, 1996)
  • K935102 — SATURN LIGHT (June 27, 1994)
  • K942553 — GENESIS (June 23, 1994)
  • K936088 — WAVE FLUORESCENT MAGNIFIER (April 26, 1994)
  • K931645 — HALUX TASKLIGHT (August 20, 1993)
  • K901706 — LIGHT, HEAD, EXAMINATION (July 19, 1990)

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)
  • K935832 — CHROMOPHARE (February 3, 1994)
  • K934259 — AC-POWERED MEDICAL EXAMINATION LIGHT (January 28, 1994)
  • K932719 — RITTER MODEL 158 AND 159 EXAM LIGHTS (December 2, 1993)

FDA data resources