FDA 510(k) Application Details - K973642

Device Classification Name	Unit, X-Ray, Extraoral With Timer   More FDA Info for this Device
510(K) Number	K973642
Device Name	Unit, X-Ray, Extraoral With Timer
Applicant	INSTRUMENTARIUM IMAGING, INC. 300 WEST EDGERTON AVE. MILWAUKEE, WI 53207-6025 US Other 510(k) Applications for this Company
Regulation Number	872.1800   More FDA Info for this Regulation Number
Classification Product Code	EHD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/24/1997
Decision Date	11/21/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review