FDA.reportPublic FDA data

FONDCIRCLE INC.

Matched from indexed company URL: FondCircle Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30346032793034603279FONDCIRCLE INC.1Y2026-01-014695 MacArthur Court 11th Floor Newport Beach CA US 92660

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3348522039547180K243306Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-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, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T)QRL2024-11-15
3348521549181354K241351Blood Pressure Monitor (TMB-2092-G)DXN2024-08-21
3348521115587299K240102Blood Pressure Monitor (TMB-2287-B)DXN2024-04-29
3348521609002680K233130Blood Pressure MonitorDXN2023-12-20
3348521440967235K232989Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E)DQA2024-07-01
3348521543220393K232128Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)FLL2023-10-14
3348521727452536K230423Electronic Peak Flow MeterBZH2024-02-23
3348521848166157K222994Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33BDXN2023-07-26
3348521754520666K222125Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30GDXN2022-12-01
3348521155086953K220475Lancet (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
3348521777222288K213485Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25EFLL2022-05-25
3348521973252115K191657Bioland Blood Glucose Monitoring SystemNBW2020-03-20
3348521155157304K173140VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring SystemNBW2018-12-19
3348521917859060K170954Portable ECG MonitorDPS2017-05-30
3348521015384894
3348521244554774

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXN52024-08-21
QRL22024-11-15
FLL22023-10-14
NBW22020-03-20
DQA12024-07-01
BZH12024-02-23
DPS12017-05-30

GUDID#