Data / Medical devices / United States / Ensodata, Inc.
Ensodata, Inc.: FDA-registered device maker in Madison, WI, United States, 4 510(k) clearances
Ensodata, Inc. is registered with the FDA (registration 3013724298) in Madison, WI, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 9, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013724298
- Address
- 10 E Doty St. Suite 449, Madison, WI, United States, 53703
- Owner or operator
- EnsoData, Inc. (10055296)
- Roles
- Manufacturer
- First device listed
- July 3, 2017
- Registered through
- 2026
- Brand names listed
- Celeste+, Drowzle, EnsoHST, EnsoSleep, EnsoSleep PPG
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automatic Event Detection Software For Polysomnograph With Electroencephalograph | OLZ | 2 | Manufacturer | accessdata.fda.gov |
| Ventilatory Effort Recorder | MNR | 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 |
|---|---|---|---|---|---|---|
| February 9, 2024 | K231355 | Aurora | MNR | Substantially Equivalent | Ensodata | accessdata.fda.gov |
| June 16, 2021 | K210034 | EnsoSleep | OLZ | Substantially Equivalent | Ensodata, Inc. | accessdata.fda.gov |
| July 14, 2019 | K173974 | DROWZLE | MNR | Substantially Equivalent | Resonea, Inc. | accessdata.fda.gov |
| March 31, 2017 | K162627 | EnsoSleep | OLZ | Substantially Equivalent | Ensodata, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Automatic Event Detection Software For Polysomnograph With Electroencephalograph
- All makers of Ventilatory Effort Recorder
Updated February 9, 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.