FDA 510(k) Application Details - K992425

Device Classification Name	Electrocardiograph,Ambulatory(Without Analysis)   More FDA Info for this Device
510(K) Number	K992425
Device Name	Electrocardiograph,Ambulatory(Without Analysis)
Applicant	TES ELECTRICAL ELECTRONIC CORP. NO.57 JEN-AI ROAD SEC. 2 TAIPEI, TAIWAN 300 300 CN Other 510(k) Applications for this Company
Contact	MIKE Z CHEN Other 510(k) Applications for this Contact
Regulation Number	870.2800   More FDA Info for this Regulation Number
Classification Product Code	MWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/21/1999
Decision Date	10/19/1999
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