Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017660607

FEI Number

3017660607

Entity Name

NIGHTWARE

City/State/Country

Hopkins, MN, US

Establishment Address

8900 EXCELSIOR BLVD, Hopkins, MN 55343, US

Establishment Type(s)

Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

NightWare (Owner Number: 10079063)

Owner / Operator Contact Address

8900 EXCELSIOR BLVD, Hopkins, MN 55343, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN200033

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QMZ	Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions	Neurology	Class 2	882.5705	2020-11-17

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NightWare

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017660607. Last updated year: 2026. Please use registration number 3017660607 when referencing this establishment in official correspondence.