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FDA 510(k) Application Details - K213645
Device Classification Name
More FDA Info for this Device
510(K) Number
K213645
Device Name
ClearPoint Maestro Brain Model
Applicant
ClearPoint Neuro, Inc.
5 Musick
Irvine, CA 92618 US
Other 510(k) Applications for this Company
Contact
Pete Piferi
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/18/2021
Decision Date
08/08/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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