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FDA 510(k) Application Details - K172716
Device Classification Name
More FDA Info for this Device
510(K) Number
K172716
Device Name
V2K Rinspiration System
Applicant
V2K Medical Inc.
1221 Innsbruck Drive
Sunnyvale, CA 94089 US
Other 510(k) Applications for this Company
Contact
Jake Wolenberg
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QEW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/08/2017
Decision Date
01/26/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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