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510(k) K934092

CAMERA, SURGICAL AND ACCESSORIES by Envision Medical Corp. — Product Code FWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1994
Date Received
August 23, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Television, Surgical, Without Audio
Device Class
Class I
Regulation Number
878.4160
Review Panel
SU
Submission Type

Other clearances by Envision Medical Corp.

  • K970605 — 3-CCD DIGITAL CAMERA (May 22, 1997)
  • K953438 — SURGICAL INTEGRATED CAMERA SYSTEM (November 6, 1995)
  • K951971 — XENON LIGHT SOURCE (May 24, 1995)
  • K944707 — ISOLATED CAMERA HEAD (October 7, 1994)

Other clearances for product code FWB

  • K902359 — SURGICAL VIDEO CAMERA, MODEL 9500 (July 12, 1990)
  • K884343 — SONY COLOR VIDEO CAMERAS AND ACCESSORIES (November 1, 1988)
  • K871057 — MC-SERIES SURGICAL CAMERAS (April 3, 1987)
  • K855020 — MEDICAL DYNAMICS CCD SOLID STATE VIDEO CAMERA 5930 (January 24, 1986)
  • K820829 — MEDICAM (May 3, 1982)