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510(k) K141208

DYNAMIC NEUROSCREENING DEVICE by Prosenex — Product Code LQW

K141208 is an FDA 510(k) premarket notification submitted by Prosenex for the device "DYNAMIC NEUROSCREENING DEVICE". The FDA issued a decision of Substantially Equivalent on July 23, 2014. The device falls under product code LQW (Test, Temperature Discrimination), a Class I device regulated under 21 CFR 882.1200.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 23, 2014
Date Received: May 9, 2014
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Test, Temperature Discrimination
Device Class: Class I
Regulation Number: 882.1200
Review Panel: NE
Submission Type