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510(k) K183053

Olympus Small Intestinal Capsule Endoscope System by Olympus Medical Systems Corp. — Product Code NEZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2019
Date Received
November 2, 2018
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

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  • K183192 — CapsoCam Plus (SV-3) (April 19, 2019)
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