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510(k) K041494

OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2 by Olympus Corporation — Product Code FET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2004
Date Received
June 4, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To allow for visualization of body cavities through an endoscope by projecting images to a monitor.

Other clearances by Olympus Corporation

  • K072643 — CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US (November 16, 2007)
  • K043128 — OLYMPUS ENDOARM (December 21, 2004)
  • K042140 — OLYMPUS BF TYPE UC160-OL8 (August 18, 2004)
  • K040940 — BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM (April 19, 2004)

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