FDA 510(k) Application Details - K151050

Device Classification Name	Device, Biofeedback   More FDA Info for this Device
510(K) Number	K151050
Device Name	Device, Biofeedback
Applicant	Power Medical Devices, LLC 1615 S.Congress Ave, Ste 13 Delray Beach, FL 33445 US Other 510(k) Applications for this Company
Contact	Patricia Palmer Other 510(k) Applications for this Contact
Regulation Number	882.5050   More FDA Info for this Regulation Number
Classification Product Code	HCC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/20/2015
Decision Date	12/22/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review