Data / Medical devices / United States / Nightware
Nightware: FDA-registered device maker in Hopkins, MN, United States, 1 510(k) clearance
Nightware is registered with the FDA (registration 3017660607) in Hopkins, MN, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 6, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017660607
- Address
- 8900 Excelsior BLVD, Hopkins, MN, United States, 55343
- Owner or operator
- NightWare (10079063)
- Roles
- Manufacturer, Specification developer
- First device listed
- November 17, 2020
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions | QMZ | 2 | 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 |
|---|---|---|---|---|---|---|
| November 6, 2020 | DEN200033 | NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable | QMZ | Unknown | Nightware, Inc. | accessdata.fda.gov |
Updated November 6, 2020. 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.