FDA 510(k) Application Details - K982228

Device Classification Name	Transmitters And Receivers, Electrocardiograph, Telephone   More FDA Info for this Device
510(K) Number	K982228
Device Name	Transmitters And Receivers, Electrocardiograph, Telephone
Applicant	TZ MEDICAL, INC. 15858 S.W. UPPER BOONES FERRY RD. LAKE OSWEGO, OR 97035 US Other 510(k) Applications for this Company
Contact	BYRON ZAHLER 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	06/25/1998
Decision Date	01/14/1999
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