FDA 510(k) Application Details - K040012

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K040012
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	ZOE MEDICAL, INC. 460 BOSTON ST. TOPSFIELD, MA 01983-1223 US Other 510(k) Applications for this Company
Contact	STEPHEN STAATS 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	01/05/2004
Decision Date	04/02/2004
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