Data / Medical devices / United States / Ventis Medical Inc
Ventis Medical Inc: FDA-registered device maker in Princeton, NJ, United States, 1 510(k) clearance
Ventis Medical Inc is registered with the FDA (registration 3021607937) in Princeton, NJ, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 13, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021607937
- Address
- 515 Executive Dr, Princeton, NJ, United States, 08540
- Owner or operator
- Ventis Medical Inc. (10091988)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- November 22, 2024
- Registered through
- 2026
- Brand names listed
- Herovent, VM-531UEN OXYGEN ENRICHMENT KIT, VM2000 Emergency and Transport Ventilator
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Connector, Airway (Extension) | BZA | 1 | Manufacturer | accessdata.fda.gov |
| Ventilator, Continuous, Facility Use | CBK | 2 | Complaint file establishment, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| August 13, 2024 | K240807 | VM-2000 | CBK | Substantially Equivalent | Ventis Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 13, 2024. 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.