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510(k) K071698

AURORA LED SERIES SURGICAL LIGHTS by Skytron, Div. the Kmw Group, Inc. — Product Code FSY

K071698 is an FDA 510(k) premarket notification submitted by Skytron, Div. the Kmw Group, Inc. for the device "AURORA LED SERIES SURGICAL LIGHTS". The FDA issued a decision of Substantially Equivalent on July 6, 2007. The device falls under product code FSY (Light, Surgical, Ceiling Mounted), a Class II device regulated under 21 CFR 878.4580. Skytron, Div. the Kmw Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2007
Date Received
June 21, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Light, Surgical, Ceiling Mounted
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Skytron, Div. the Kmw Group, Inc.

  • K021585 — STELLAR SERIES SURGICAL LIGHTS WITH HERMES (November 13, 2002)
  • K002463 — STELLAR (November 8, 2000)
  • K992090 — MILLENNIUM GOLD (September 8, 1999)
  • K950192 — SKYTRON SKYBOOM SERIES (April 3, 1995)
  • K940616 — SKYTRON ELITE 3500 TABLE (June 13, 1994)
  • K933564 — SKYTRON EXAM LIGHT (February 10, 1994)
  • K926045 — SKYTRON LIFE ISLAND 21 (July 27, 1993)
  • K915285 — SKYTRON INFINITY SERIES SURGICAL LIGHTS (February 20, 1992)
  • K900472 — SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI (September 4, 1990)
  • K900211 — SKYTRON UNIVERSE SERIES SURGICAL LIGHTS (March 19, 1990)

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)
  • K140460 — MACH LED 2SC (April 3, 2014)
  • K140461 — MACH LED 2MC (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)

FDA data resources