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510(k) K830924

CRM-114 COLOR VIDEO CAMERA by Umi, Inc. — Product Code FET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1983
Date Received
March 22, 1983
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 Umi, Inc.

  • K883527 — GRID/RADIOGRAPHIC (September 2, 1988)
  • K831412 — CRM-100 COLOR VIDEO CAMERA (June 3, 1983)
  • K823382 — NEPHROSTOMY CATHETER (January 28, 1983)

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