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FDA 510(k) Application Details - K032996
Device Classification Name
Accelerator, Linear, Medical
More FDA Info for this Device
510(K) Number
K032996
Device Name
Accelerator, Linear, Medical
Applicant
ELEKTA ONCOLOGY SYSTEMS, LTD.
4775 PEACHTREE INDUSTRIAL BLVD
BLDG 300, SUITE 300
NORCROSS, GA 30092 US
Other 510(k) Applications for this Company
Contact
PETER STEGAGNO
Other 510(k) Applications for this Contact
Regulation Number
892.5050
More FDA Info for this Regulation Number
Classification Product Code
IYE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/25/2003
Decision Date
10/23/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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