FDA 510(k) Application Details - K982384

Device Classification Name	Recorder, Magnetic Tape, Medical   More FDA Info for this Device
510(K) Number	K982384
Device Name	Recorder, Magnetic Tape, Medical
Applicant	HARLEY STREET SOFTWARE LTD. 771 VANALMAN AVE. VICTORIA, B.C. V87 3B8 CA Other 510(k) Applications for this Company
Contact	BRUCE WEBSTER 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	07/08/1998
Decision Date	01/27/1999
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