FDA.reportPublic FDA data

NUVOAIR AB

Matched from indexed company URL: NUVO, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30137447633013744763NUVOAIR AB1N2026-01-01Riddargatan 17D 3 tr Stockholm SE 11457
30144492593014449259NUVOMED INC1Y2026-01-012101 W 21st St Broadview IL US 60155
30168297043016829704Nuvo Intl Group Inc.1N2026-01-012980 NE 207TH ST. Aventura FL US 33180
30250295553025029555NUVOLA WORLD S.R.L.1N2026-01-01via zamenhof 615 vicenza IT 36100
30075907003007590700Nuvolase Inc.1N2020-04-2511 Ilahee Ln Chico CA US 95973

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2425451470275814K231416Air Next (NVD-02)BZG2024-01-18
3111351102799276K222418NuvolaNXC2022-10-07
2614151845355544K221046Invu by NuvoLQK2022-05-06
2614151914483434K210025INVU by NuvoLQK2021-05-28
2259441925010267K203347Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow MaskBZD2021-07-02
2614151083792610K191401PregSenseLQK2020-03-27
2425451473774931K183089Air NextBZG2020-01-02
2259441998477006K152863Portable ECG MonitorDPS2016-06-22
1163371837672367K130413PINPOINTE FOOTLASERGEX2013-03-21
1163372015450525K093547PINPOINTE FOOTLASERPDZ2010-10-15
2259441417953538
2259441046046659
2259441068432120
2259441109393170
3111351266510685
2259441603552278
2259441931460665
2259441933922839
2259441950166878
2259442021987369

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
BZG32024-01-18
LQK32022-05-06
NXC12022-10-07
BZD12021-07-02
DPS12016-06-22
GEX12013-03-21
PDZ12010-10-15

NDC#

PMN#

Applications#

GUDID#

Invu by Nuvo - The INVU by Nuvo™ System is a safe, non-invasive wearable monitoring system that provides continuous passive monitoring of vital pregnancy data of the pregnant person and the fetus through the INVU™ App. The information it provides is: Fetal heart rate (FHR), Maternal heart rate (MHR), and Uterine Activity (UA).The INVU by Nuvo™ System (as a part of the INVU 3200 Family/Catalogue) includes a wearable sensory band NV-BTSH-3000 (INVU Sensor Band™) that connects wirelessly to the INVU™ App installed on the pregnant person’s mobile device. The system may include additional peripheral devices, such as a blood pressure measuring device, depending on the care plan prescribed by the pregnant person’s medical supervisor. The INVU™ App installed on the pregnant person’s smartphone can log the measured blood pressure. The monitored pregnancy data is displayed on the mobile device by the INVU™ App. The recorded monitored pregnancy data can also be viewed by an assigned medical supervisor (or by a remote monitoring medical service), using the INVU Pro™ web application.

Nuvo Group Usa, Inc.

2023-07-05

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