Device Classification Name |
System, Tomography, Computed, Emission
More FDA Info for this Device |
510(K) Number |
K963162 |
Device Name |
System, Tomography, Computed, Emission |
Applicant |
ELSCINT, INC.
505 MAIN ST.
SUITE 300
HACKENSACK, NJ 07601 US
Other 510(k) Applications for this Company
|
Contact |
THOMAS J SPACKMAN, M.D.,F.A.C.R.
Other 510(k) Applications for this Contact |
Regulation Number |
892.1200
More FDA Info for this Regulation Number |
Classification Product Code |
KPS
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
08/14/1996 |
Decision Date |
11/12/1996 |
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 |
|