FDA 510(k) Application Details - K982412

Device Classification Name	System, Hemodialysis, Access Recirculation Monitoring   More FDA Info for this Device
510(K) Number	K982412
Device Name	System, Hemodialysis, Access Recirculation Monitoring
Applicant	IN-LINE DIAGNOSTICS CORP. 117 WEST 200 SOUTH FARMINGTON, UT 84025 US Other 510(k) Applications for this Company
Contact	MATTHEW L HAYNIE Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	MQS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/13/1998
Decision Date	10/09/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review