FDA 510(k) Application Details - K010955

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K010955
Device Name	Electrocardiograph
Applicant	BOSTON MEDICAL TECHNOLOGIES, INC. 591 NORTH AVE., SUITE 5 WAKEFIELD, MA 01880-1641 US Other 510(k) Applications for this Company
Contact	CESIDIO TEMPESTA Other 510(k) Applications for this Contact
Regulation Number	870.2340   More FDA Info for this Regulation Number
Classification Product Code	DPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/30/2001
Decision Date	04/26/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review