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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Neurological
510(k) Number K180270
Device Name Cellvizio 100 Series Systems with Confocal Miniprobes
Applicant
Mauna Kea Technologies
9 Rue D'Enghien
Paris,  FR 75010
Applicant Contact Veronique Dentan
Correspondent
Daniel & Daniel Consulting
340 Jones Ln.
Gardnerville,  NV  89460
Correspondent Contact Michael A. Daniel
Regulation Number882.1480
Classification Product Code
GWG  
Subsequent Product Code
OWN  
Date Received01/31/2018
Decision Date 05/22/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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