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FDA 510(k) Application Details - K213882
Device Classification Name
More FDA Info for this Device
510(K) Number
K213882
Device Name
EarliPoint System
Applicant
EarliTec Diagnostics, Inc.
755 Commerce Drive, Suite 700
Decatur, GA 30030 US
Other 510(k) Applications for this Company
Contact
Thomas Ressemann
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QPF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/13/2021
Decision Date
06/08/2022
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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