FDA 510(k) Application Details - K981745

Device Classification Name	Transducer, Blood-Pressure, Extravascular   More FDA Info for this Device
510(K) Number	K981745
Device Name	Transducer, Blood-Pressure, Extravascular
Applicant	SUNSCOPE INTL., INC. 20250 ACACIA ST., SUITE 115 NEWPORT BEACH, CA 92660 US Other 510(k) Applications for this Company
Contact	JOHN SHULZE Other 510(k) Applications for this Contact
Regulation Number	870.2850   More FDA Info for this Regulation Number
Classification Product Code	DRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/18/1998
Decision Date	07/17/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review