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FDA 510(k) Application Details - K214065
Device Classification Name
Neurological Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K214065
Device Name
Neurological Stereotaxic Instrument
Applicant
Medtech S.A.S
432 rue du Rajol
Mauguio 34130 FR
Other 510(k) Applications for this Company
Contact
Paul Hardy
Other 510(k) Applications for this Contact
Regulation Number
882.4560
More FDA Info for this Regulation Number
Classification Product Code
HAW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/27/2021
Decision Date
05/04/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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