FDA.reportPublic FDA data

1BYONE PRODUCTS INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
301239336630123933661BYONE PRODUCTS INC.1Y2020-04-251230 E Belmont Street Ontario CA US 91761

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1924361722508339K180435Arm Blood Pressure MonitorDXN2019-01-03
1924361936238221K170954Portable ECG MonitorDPS2017-05-30
1924361814764493K162517Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13NUH2017-04-14
1924361718137006K153520Electronic Pulse StimulatorNUH2016-05-05
1924361272968191K140582FINGERTIP PULSE OXIMETERDQA2014-08-28
1924361360071647K131395TRANSTEK BLOOD PRESSURE MONITORDXN2013-06-19
1924361093593900K131243NON-CONTACT INFRARED THERMOMETERFLL2013-11-12
1924361557726207K120058TRANSTEK BLOOD PRESSURE MONITORDXN2012-01-31
1924361268520770K081160AVITA RADAR THERMO IR THERMOMETER, NT1 SERIESFLL2008-06-24

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXN32019-01-03
NUH22017-04-14
FLL22013-11-12
DPS12017-05-30
DQA12014-08-28

GUDID#