FDA.reportPublic FDA data

QUALITEL CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30246733024673QUALITEL CORPORATION1N2026-01-0111831 Beverly Park Road, Bldg A Everett WA US 98204

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
422051693321621K192556Carnation Ambulatory MonitorDSH2019-10-17
422051030862672K191471Carnation Ambulatory MonitorDSH2019-08-30
422051732063840K191000Carnation Ambulatory MonitorDSH2019-05-16
422051038946943
422051089726187
422051154699806
422051233612947
422051391761274
422051528975474
422051866459915
422052001355516
422052049630616

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DSH32019-10-17