FDA 510(k) Application Details - K013354

Device Classification Name	Recorder, Magnetic Tape, Medical   More FDA Info for this Device
510(K) Number	K013354
Device Name	Recorder, Magnetic Tape, Medical
Applicant	CARDIOCOMM SOLUTIONS, INC. 3060 CEDAR HILL RD., SUITE 201 VICTORIA, B.C. V8T 3J5 CA Other 510(k) Applications for this Company
Contact	ANGELA HALWAS Other 510(k) Applications for this Contact
Regulation Number	870.2800   More FDA Info for this Regulation Number
Classification Product Code	DSH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/09/2001
Decision Date	01/31/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review