FDA 510(k) Application Details - K971604

Device Classification Name	Recorder, Magnetic Tape, Medical   More FDA Info for this Device
510(K) Number	K971604
Device Name	Recorder, Magnetic Tape, Medical
Applicant	ALEXANDER MFG. CO. 1511 S GARFIELD PL MASON CITY, IA 50401 US Other 510(k) Applications for this Company
Contact	KEN HEIMENDINGER 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	05/01/1997
Decision Date	07/28/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review