FDA 510(k) Application Details - K082167

Device Classification Name	Unit, X-Ray, Extraoral With Timer   More FDA Info for this Device
510(K) Number	K082167
Device Name	Unit, X-Ray, Extraoral With Timer
Applicant	DIGIMED CORPORATION 215 S. STATE STREET, STE 100B SALT LAKE CITY, UT 84111 US Other 510(k) Applications for this Company
Contact	SHIN KUK YOO Other 510(k) Applications for this Contact
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	07/31/2008
Decision Date	09/26/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review