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510(k) K020301

MODIFICATION TO VISTA STEREOSCOPE SYSTEM by Vista Medical Technologies, Inc. — Product Code FET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2002
Date Received
January 29, 2002
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 Vista Medical Technologies, Inc.

  • K021290 — VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYSTEM WITH VOICE AC (June 28, 2002)
  • K991303 — VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE (July 12, 1999)
  • K990635 — VISTA STEREOSCOPE SYSTEM (May 19, 1999)
  • K973436 — VISTA HEAD MOUNTED DISPLAY (December 9, 1997)
  • K971373 — VISTA SINGLE CHIP VIDEO CAMERA (May 20, 1997)
  • K970217 — VISTA ILLUMINATION SYSTEM (April 2, 1997)
  • K961800 — HEAD MOUNTED DISPLAY (September 11, 1996)
  • K953888 — TELESCOPE 4MM, 2.7MM DIAM. WIDE ANGLE 0', 30', 70', 4MM, DIAM, 30' WORK, L 14CM, (October 7, 1995)

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