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FDA 510(k) Application Details - K203764
Device Classification Name
More FDA Info for this Device
510(K) Number
K203764
Device Name
TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform
Applicant
Imperative Care Inc.
1359 Dell Avenue
Campbell, CA 95008 US
Other 510(k) Applications for this Company
Contact
Kristin Ellis
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QJP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/23/2020
Decision Date
03/03/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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