FDA 510(k) Application Details - K192958

Device Classification Name	Stimulator, Nerve, Peripheral, Electric   More FDA Info for this Device
510(K) Number	K192958
Device Name	Stimulator, Nerve, Peripheral, Electric
Applicant	Blink Device Company 1530 Westlake Ave N Suite 600 Seattle, WA 98109 US Other 510(k) Applications for this Company
Contact	Justin Hulvershorn 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	10/22/2019
Decision Date	04/02/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review