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510(k) K132551

ZF 720 by Umbel Corporation — Product Code FSY

K132551 is an FDA 510(k) premarket notification submitted by Umbel Corporation for the device "ZF 720". The FDA issued a decision of Substantially Equivalent on June 30, 2014. The device falls under product code FSY (Light, Surgical, Ceiling Mounted), a Class II device regulated under 21 CFR 878.4580.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2014
Date Received
August 14, 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 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)
  • 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)
  • K122875 — ORICARE L2700 (December 18, 2012)

FDA data resources