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510(k) K912447

SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200 by Medical Laser, Inc. — Product Code FET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1991
Date Received
June 3, 1991
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 Medical Laser, Inc.

  • K913136 — LASER ENDOSCOPE DISC DECOMPRESSION KITS (November 1, 1991)
  • K912265 — MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000 (October 10, 1991)
  • K912089 — MODIFIED SERIES 2100 ENDOSCOPES (August 12, 1991)
  • K901464 — MEDILASE SERIES 2200 ENDOSCOPE (August 7, 1990)
  • K900894 — MEDILASE SERIES 2100 ENDOSCOPE (June 22, 1990)
  • K900380 — MEDILASE 5010 ENDOSCOPE CONSOLE (May 15, 1990)
  • K895837 — MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR (December 14, 1989)

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