FDA 510(k) Application Details - K020084

Device Classification Name	Detector And Alarm, Arrhythmia   More FDA Info for this Device
510(K) Number	K020084
Device Name	Detector And Alarm, Arrhythmia
Applicant	FUKUDA DENSHI USA, INC. 17725 N.E. 65TH ST., BLDG. C REDMOND, WA 98052-4911 US Other 510(k) Applications for this Company
Contact	LARRY D WALKER Other 510(k) Applications for this Contact
Regulation Number	870.1025   More FDA Info for this Regulation Number
Classification Product Code	DSI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/10/2002
Decision Date	02/06/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review