FDA.reportPublic FDA data

Ensodata

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30137242983013724298ENSODATA, INC.1N2026-01-0110 E Doty St. Suite 449 Madison WI US 53703

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00864458000407EnsoSleep - Automated sleep scoring software.6085094704brock@ensodata.io

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2093091073478062K231355AuroraMNR2024-02-09
2093091730677825K210034EnsoSleepOLZ2021-06-16
2093091243356146K173974DROWZLEMNR2019-07-14
2093091973625699K162627EnsoSleepOLZ2017-03-31

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MNR22024-02-09
OLZ22021-06-16

PMN#

GUDID#

EnsoTherapy - EnsoTherapy is a clinical decision support (CDS)/Medical Device Data System (MDDS) non-medical device product that allows clinicians, clinical support staff, or administrators to identify and prioritize patients that could benefit from sleep disorder treatment adherence support.Treatment and communication data are imported into the software component, which is used to generate compliance projections, risk scores, and prioritized tasks for each patient. Information and tasks generated are used by clinicians in their decisions on how to prioritize patient coaching outreach.

Ensodata, Inc.

2023-11-20