Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3044462812

FEI Number

3044462812

Entity Name

LUTSO INC.

City/State/Country

Livingston, TX, US

Establishment Address

101 Rainbow Dr, Pmb 11758, Livingston, TX 77399, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Lutso Inc. (Owner Number: 10095341)

Owner / Operator Contact Address

101 RAINBOW DRIVE, Pmb 11758, Livingston, TX 77399, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nightwatch Caregiver System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMI	Monitor, Bed Patient	General Hospital	Class 1	880.2400	2026-03-01

Official Correspondent

Andres-Toomas Tuul

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Lutso Inc.

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 3044462812. Last updated year: 2026. Please use registration number 3044462812 when referencing this establishment in official correspondence.