Home / 510(k) Clearances / K153369

510(k) K153369

SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz by Volcano Corporation — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2015
Date Received
November 23, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

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