FDA 510(k) Application Details - K092576

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K092576
Device Name	Electrocardiograph
Applicant	GEM-MED S.L. CALLE CARTAGENA, 5E, OF. 5-6 BARCELONA 08025 ES Other 510(k) Applications for this Company
Contact	WILSON TSENG 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	08/21/2009
Decision Date	09/04/2009
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	Y
Expedited Review