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510(k) K210109

visor2 system by Eemagine Medical Imaging Solutions GmbH — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2022
Date Received
January 19, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurological Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
NE
Submission Type

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