Data / Medical devices / United States / Nuvo Intl Group Inc.
Nuvo Intl Group Inc.: FDA-registered device maker in Aventura, FL, United States, 3 510(k) clearances
Nuvo Intl Group Inc. is registered with the FDA (registration 3016829704) in Aventura, FL, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated May 6, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016829704
- Address
- 2980 Ne 207TH ST., Aventura, FL, United States, 33180
- Owner or operator
- Nuvo Intl Group Inc (10071666)
- Roles
- Manufacturer
- First device listed
- April 23, 2020
- Registered through
- 2026
- Brand names listed
- INVO by Nuvo, Invo by Nuvo, PregSense
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Home Uterine Activity Monitor | LQK | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 6, 2022 | K221046 | Invu by Nuvo | LQK | Substantially Equivalent | Nuvo- Group , Ltd. | accessdata.fda.gov |
| May 28, 2021 | K210025 | INVU by Nuvo | LQK | Substantially Equivalent | Nuvo- Group , Ltd. | accessdata.fda.gov |
| March 27, 2020 | K191401 | PregSense | LQK | Substantially Equivalent | Nuvo- Group , Ltd. | accessdata.fda.gov |
Updated May 6, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.