FDA 510(k) Application Details - K003775

Device Classification Name	Camera, Scintillation (Gamma)   More FDA Info for this Device
510(K) Number	K003775
Device Name	Camera, Scintillation (Gamma)
Applicant	PEM TECHNOLOGIES 12300 TWINBROOK PKWY. SUITE 625 BOCKVILLE, MD 20852 US Other 510(k) Applications for this Company
Contact	T. WHIT ATHEY Other 510(k) Applications for this Contact
Regulation Number	892.1100   More FDA Info for this Regulation Number
Classification Product Code	IYX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/06/2000
Decision Date	01/12/2001
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