FDA 510(k) Application Details - K070818

Device Classification Name	Recorder, Magnetic Tape, Medical   More FDA Info for this Device
510(K) Number	K070818
Device Name	Recorder, Magnetic Tape, Medical
Applicant	TOM MEDICAL ENTWICKLUNGS GMBH ANZENGRUBERGASSE 8 GRAZ A-8010 AT Other 510(k) Applications for this Company
Contact	THOMAS HASIBA 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	03/26/2007
Decision Date	04/06/2007
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	Y
Expedited Review