510(k) K152831

Spot Skan by Skanray Technologies Private Limited — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2016
Date Received
September 29, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type