FDA 510(k) Application Details - K011310

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K011310
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	NIEN MADE ELECTRNICS CORP. 100 MAIN ST. SUITE 120 CONCORD, MA 01742 US Other 510(k) Applications for this Company
Contact	JAMES M DELANEY Other 510(k) Applications for this Contact
Regulation Number	870.1130   More FDA Info for this Regulation Number
Classification Product Code	DXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2001
Decision Date	07/20/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review