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FDA 510(k) Application Details - K092018
Device Classification Name
Accelerator, Linear, Medical
More FDA Info for this Device
510(K) Number
K092018
Device Name
Accelerator, Linear, Medical
Applicant
IBA DOSIMETRY GMBH
3150 STAGE POST DR
SUITE 110
BARTLETT, TN 38133 US
Other 510(k) Applications for this Company
Contact
CHUCK LINDLEY
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
07/06/2009
Decision Date
09/18/2009
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
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