FDA.reportPublic FDA data

ELEKTA LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30047475353004747535ELEKTA LTD.1N2020-04-252050 BLEURY, SUITE 200 MONTREAL Quebec CA H3A 2J5
30083177223008317722ELEKTA LTD.1N2020-04-25555 Richmond Street West, Suite 1001 Toronto Ontario CA M5V3B1

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
635351581883197K141855CLARITYIYE2014-10-08
635351524047479K121663CLARITYIYE2012-12-05
635351315552049K041937RESTITUIYE2004-11-16
2342992055314092

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYE32014-10-08

PMN#