FDA 510(k) Application Details - K033550

Device Classification Name	Densitometer, Bone   More FDA Info for this Device
510(K) Number	K033550
Device Name	Densitometer, Bone
Applicant	DEMETECH AB DALVAGEN 24 SOLNA 16956 SE Other 510(k) Applications for this Company
Contact	JOAKIM ARWIDSON Other 510(k) Applications for this Contact
Regulation Number	892.1170   More FDA Info for this Regulation Number
Classification Product Code	KGI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2003
Decision Date	05/05/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review