FDA 510(k) Application Details - K981119

Device Classification Name	Transmitters And Receivers, Electrocardiograph, Telephone   More FDA Info for this Device
510(K) Number	K981119
Device Name	Transmitters And Receivers, Electrocardiograph, Telephone
Applicant	MEDICOMP, INC. 7845 ELLIS RD. WEST MELBOURNE, FL 32904 US Other 510(k) Applications for this Company
Contact	JOSEPHUS RIFFE 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	03/27/1998
Decision Date	10/14/1998
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