FDA 510(k) Application Details - K162048

Device Classification Name	Stimulator, Nerve, Peripheral, Electric   More FDA Info for this Device
510(K) Number	K162048
Device Name	Stimulator, Nerve, Peripheral, Electric
Applicant	HALYARD HEALTH - IRVINE 43 DISCOVERY, SUITE 100 IRVINE, CA 92618 US Other 510(k) Applications for this Company
Contact	Maria Pronina Other 510(k) Applications for this Contact
Regulation Number	868.2775   More FDA Info for this Regulation Number
Classification Product Code	KOI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/25/2016
Decision Date	12/05/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review