FDA 510(k) Application Details - K973735

Device Classification Name	Recorder, Magnetic Tape, Medical   More FDA Info for this Device
510(K) Number	K973735
Device Name	Recorder, Magnetic Tape, Medical
Applicant	SCHILLER AMERICA, INC. 3002 DOW AVE., #138 TUSTIN, CA 92780 US Other 510(k) Applications for this Company
Contact	MARKUS MARITZ 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	09/30/1997
Decision Date	08/25/1998
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