FDA 510(k) Application Details - K993813

Device Classification Name	Camera, Scintillation (Gamma)   More FDA Info for this Device
510(K) Number	K993813
Device Name	Camera, Scintillation (Gamma)
Applicant	GAMMA MEDICA 19355 BUSINESS CENTER DR., SUITE 8 NORTHRIDGE, CA 91324 US Other 510(k) Applications for this Company
Contact	BRADLEY E PATT 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	11/10/1999
Decision Date	01/18/2000
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