FDA 510(k) Application Details - K191470

Device Classification Name	Catheter, Conduction, Anesthetic   More FDA Info for this Device
510(K) Number	K191470
Device Name	Catheter, Conduction, Anesthetic
Applicant	Cimpax ApS Lille Pilevang 4 Slangerup 3550 DK Other 510(k) Applications for this Company
Contact	Patrick Busch-Madsen Other 510(k) Applications for this Contact
Regulation Number	868.5120   More FDA Info for this Regulation Number
Classification Product Code	BSO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/03/2019
Decision Date	10/25/2019
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