FDA.reportPublic FDA data

Samsung HME America, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30049387663004938766Samsung HME America, Inc.1Y2026-01-0114 Electronics Ave Danvers MA US 01923

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1851511249089317K250928OmniTom Elite with PCDJAK2025-09-08
1851511893954833K242811BodyTom 64JAK2025-03-14
1851511425413547K233767OmniTom EliteJAK2024-06-10
1851511233907927K223447OmniTom EliteJAK2023-06-01
1851511430487483K211711OmniTom EliteJAK2022-02-25
1851511478984477K172539CereTom EliteJAK2017-11-22
1851511031034050K171183OmniTomJAK2017-08-18
1851511629028626K171085GMR40MQB2017-05-11
1851511183029559K170238BodyTom EliteJAK2017-06-14
1851511703661423K142697NExCT 7JAK2014-12-23
1851512056860373K102677BODYTOM NL 4000JAK2011-03-24
1851511900786331K090811INSPIRA HD, MODEL: NL1000KPS2009-08-27
1851511983069794K051765CERETOM, MODEL NL3000JAK2005-07-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JAK112025-09-08
MQB12017-05-11
KPS12009-08-27