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FDA 510(k) Application Details - K190795
Device Classification Name
Stimulator, Nerve, Peripheral, Electric
More FDA Info for this Device
510(K) Number
K190795
Device Name
Stimulator, Nerve, Peripheral, Electric
Applicant
Senzime AB
Ulls vag 29B
Uppsala 756 51 SE
Other 510(k) Applications for this Company
Contact
Johanna Faris
Other 510(k) Applications for this Contact
Regulation Number
868.2775
More FDA Info for this Regulation Number
Classification Product Code
KOI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/28/2019
Decision Date
10/18/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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