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FDA 510(k) Application Details - K203722
Device Classification Name
Accelerator, Linear, Medical
More FDA Info for this Device
510(K) Number
K203722
Device Name
Accelerator, Linear, Medical
Applicant
Micropos Medical AB
Adolf Edelsvards gata 11
Gothenburg SE414 51 SE
Other 510(k) Applications for this Company
Contact
Thomas Lindstrom
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
12/21/2020
Decision Date
09/02/2021
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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