FDA.reportPublic FDA data

PREVOUNCE HEALTH, INC

Matched from indexed company URL: Prevounce Health, Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30175009033017500903PREVOUNCE HEALTH, INC1Y2026-01-013250 N Post Road STE 180 Indianapolis IN US 46226

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2795812051132555K223722MIO Blood Glucose Monitoring SystemNBW2023-06-28
2795811083753243K220475Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T)QRL2022-07-06
2795811634278193K202891Blood Pressure MonitorDXN2021-03-09
2795811071832614K140582FINGERTIP PULSE OXIMETERDQA2014-08-28
2795811088252564K123780TRANSTEK BLOOD PRESSURE MONITORDXN2013-03-01
2795811652031192K120058TRANSTEK BLOOD PRESSURE MONITORDXN2012-01-31
2795811133644440
2795811723915410

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXN32021-03-09
NBW12023-06-28
QRL12022-07-06
DQA12014-08-28

GUDID#