FDA 510(k) Application Details - DEN180021

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN180021
Device Name	Early Bird Bleed Monitoring System
Applicant	Saranas, Inc. 2450 Holcombe Blvd. Suite X Houston, TX 77021 US Other 510(k) Applications for this Company
Contact	Zaffer Syed Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QFJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/23/2018
Decision Date	03/01/2019
Decision	DENG -
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review