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FDA 510(k) Application Details - K161458
Device Classification Name
More FDA Info for this Device
510(K) Number
K161458
Device Name
Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care
Applicant
Indiba USA Inc.
1717 Embarcadero Road
Palo Alto, CA 94303 US
Other 510(k) Applications for this Company
Contact
Carles Janer
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PBX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/26/2016
Decision Date
10/03/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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