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FDA 510(k) Application Details - K042269
Device Classification Name
System,Planning,Radiation Therapy Treatment
More FDA Info for this Device
510(K) Number
K042269
Device Name
System,Planning,Radiation Therapy Treatment
Applicant
ELEKTA INSTRUMENT AB
KUNGSTENSGATAN 18
PO BOX 7593
STOCKHOLM SE-103 93 SE
Other 510(k) Applications for this Company
Contact
ANDERS SKOGLUND
Other 510(k) Applications for this Contact
Regulation Number
892.5050
More FDA Info for this Regulation Number
Classification Product Code
MUJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/23/2004
Decision Date
09/08/2004
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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