FDA 510(k) Application Details - K001091

Device Classification Name	Transmitters And Receivers, Electrocardiograph, Telephone   More FDA Info for this Device
510(K) Number	K001091
Device Name	Transmitters And Receivers, Electrocardiograph, Telephone
Applicant	NEXT MILLENNIUM SOFTWARE SOLUTIONS, INC. 7224 WEST 29TH WAY HIALEAH, FL 33018 US Other 510(k) Applications for this Company
Contact	JUAN OMAR PEREZ Other 510(k) Applications for this Contact
Regulation Number	870.2920   More FDA Info for this Regulation Number
Classification Product Code	DXH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/04/2000
Decision Date	08/10/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review