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510(k) K123428

MIROCAM CAPSULE ENDOSCOPE SYSTEM by Intromedic Co., Ltd. — Product Code NEZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2013
Date Received
November 7, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Gastrointestinal, Wireless, Capsule
Device Class
Class II
Regulation Number
876.1300
Review Panel
GU
Submission Type

Other clearances by Intromedic Co., Ltd.

  • K180732 — MiroCam Capsule Endoscope System (November 8, 2018)
  • K170438 — MiroCam Capsule Endoscope System (January 30, 2018)
  • K143663 — MiroCam Capsule Endoscope System (March 17, 2015)
  • K134005 — MIROCAM CAPSULE ENDOSCOPE SYSTEM (July 9, 2014)
  • K140751 — MIROCAM CAPSULE ENDOSCOPE SYSTEM (June 30, 2014)
  • K131131 — E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM (June 21, 2013)
  • K120702 — E.G. SCAN II ESPHAGOSCOPE SYSTEM (June 20, 2012)
  • K111450 — MIROCAM CAPSULE ENDOSCOPE SYSTEM (May 18, 2012)
  • K111030 — E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM (October 21, 2011)

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