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510(k) K903459

PRECISION OPTICS ENDOSCOPE ADAPTER by Precise Optics — Product Code FET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1990
Date Received
August 1, 1990
Clearance Type
Traditional
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 Precise Optics

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  • K914084 — ENDOSCOPES (January 22, 1992)
  • K914184 — P2020-8-0 BEAM-LIMITING DEVICE (November 27, 1991)
  • K911744 — PRECISION OPTICS CORPORATION LAPAROSCOPE (July 26, 1991)
  • K903458 — PRECISION OPTICS IMAGE COUPLER (October 19, 1990)
  • K903457 — PRECISION OPTICS IMAGE BEAMSPLITTER (COUPLER) (October 19, 1990)
  • K820178 — PI808 MOBILE C-ARM IMAGE INTENSIFIER (March 4, 1982)
  • K827087 — P1808 MOBILE C-ARM IMAGE INTENSIFIER (March 4, 1982)

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