FDA 510(k) Application Details - K992479

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K992479
Device Name	Computer, Diagnostic, Programmable
Applicant	ENDOCARDIAL SOLUTIONS, INC. 1350 ENERGY LN., SUITE 110 ST. PAUL, MN 55108 US Other 510(k) Applications for this Company
Contact	JAMES W BULLOCK Other 510(k) Applications for this Contact
Regulation Number	870.1425   More FDA Info for this Regulation Number
Classification Product Code	DQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/26/1999
Decision Date	12/02/1999
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review