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510(k) K101537

AIM 200, MAJOR SURGICAL LIGHT by Burton Medical Products Corp. — Product Code FSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2010
Date Received
June 3, 2010
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 Burton Medical Products Corp.

  • 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)
  • K893807 — MODEL 0183010, PEARL MEDICAL EXAM LIGHT (August 15, 1989)

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)