FDA.reportPublic FDA data

MASIMO SWEDEN AB

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30054506893005450689MASIMO SWEDEN AB1N2020-04-25SVARDVAGEN 15 DANDERYD Stockholms lan [SE-01] SE SE-182 33

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
242381611640398K171121Masimo Root Monitoring System and AccessoriesMWI2017-11-17
242381302641115K123043IRMA C02 MODEL 200101; IRMA AX 200601CCK2012-10-25
242381844336441K103604ISA CO2, ISA AX+, ISA OR+CCK2011-04-06
242381016743272K081601VEO MULTIGAS MONITOR FOR POCKET PCCCK2008-09-04
242381609581793K072813EMMA ANALYZER (KPA & MMHG); EMMA MONITOR (KPA & MMHG)CCK2007-12-28
242381120875445K063167EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (MMHG)CCK2007-02-06
242381107779320K051857VEO MULTIGAS MONITOR FOR POCKET PC, MODEL 400221CCK2005-09-15

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CCK62012-10-25
MWI12017-11-17

GUDID#