FDA 510(k) Application Details - K970136

Device Classification Name	System, X-Ray, Stationary   More FDA Info for this Device
510(K) Number	K970136
Device Name	System, X-Ray, Stationary
Applicant	SWISSRAY TELERAY AG 121 METROPOLITAN DR. LIVERPOOL, NY 13088 US Other 510(k) Applications for this Company
Contact	MORTEZA MINAEE Other 510(k) Applications for this Contact
Regulation Number	892.1680   More FDA Info for this Regulation Number
Classification Product Code	KPR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/15/1997
Decision Date	11/21/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review