Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013724298

FEI Number

3013724298

Entity Name

ENSODATA, INC.

City/State/Country

Madison, WI, US

Establishment Address

10 E Doty St. Suite 449, Madison, WI 53703, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EnsoData, Inc. (Owner Number: 10055296)

Owner / Operator Contact Address

10 E Doty St, Suite 449, Madison, WI 53703, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K173974

PMA Number

N/A

All Registered Proprietary Names

EnsoSleep PPG EnsoHST EnsoSleep Drowzle Celeste+

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2024-02-19
OLZ	Automatic Event Detection Software For Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2021-07-09
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2025-02-18

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EnsoData, Inc.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K082968	Apneicare, LLC	APNEICARE CONNECTION CENTER/INTERNET ANALYSIS	2009-01-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2022	NOX MEDICAL Keldnaholt Reykjavik Iceland	2	Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

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3026753386	ONERA B.V.	Eindhoven Noord-Brabant, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013724298. Last updated year: 2026. Please use registration number 3013724298 when referencing this establishment in official correspondence.