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510(k) K212322

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2021
Date Received
July 26, 2021
Clearance Type
Special
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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  • K150831 — Cellvizio 100 Series System with Confocal Miniprobes (December 22, 2015)
  • K151593 — Cellvizio 100 Series System with Confocal Miniprobes (October 23, 2015)

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