FDA 510(k) Application Details - K173530

Device Classification Name	More FDA Info for this Device
510(K) Number	K173530
Device Name	Indego(R)
Applicant	Parker-Hannifin Corporation 1390 E. Highland Road Macedonia, OH 44056 US Other 510(k) Applications for this Company
Contact	Achilleas Dorotheou Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PHL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/15/2017
Decision Date	01/31/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review