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510(k) K193416

Cellvizio I.V.E. with Confocal Miniprobes by Mauna Kea Technologies — Product Code OWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2020
Date Received
December 9, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Confocal Optical Imaging
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

Collection of light signals for visualization of cellular microstructures.

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