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510(k) K132747

VISUM BLADE LED SURGICAL LIGHTING SYSTEM by Stryker Communications — Product Code FSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2013
Date Received
September 3, 2013
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 Stryker Communications

  • K100852 — STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000 (May 6, 2010)
  • K060802 — VISUM LED SURGICAL LIGHTING SYSTEM (April 7, 2006)
  • K033132 — STRYKER SWITCHPOINT INFINITY (September 2, 2004)

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  • K132551 — ZF 720 (June 30, 2014)
  • K140930 — VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES (June 9, 2014)
  • K140460 — MACH LED 2SC (April 3, 2014)
  • K140461 — MACH LED 2MC (April 3, 2014)
  • K132307 — VIDA LED SURGICAL LIGHTING SYSTEM (November 5, 2013)
  • K131893 — AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS (October 30, 2013)
  • K122875 — ORICARE L2700 (December 18, 2012)