Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021337298

FEI Number

3021337298

Entity Name

MIMOSA DIAGNOSTICS INC.

City/State/Country

Toronto Ontario, CA

Establishment Address

Unit 434, 366 Adelaide St East, Toronto Ontario M5A3X9, CA

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

MIMOSA Diagnostics Inc. (Owner Number: 10083796)

Owner / Operator Contact Address

Unit 434, 366 Adelaide St East, Toronto, CA-ON M5A3X9, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K190334

PMA Number

N/A

All Registered Proprietary Names

MIMOSA Pro (previously Imager)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2022-01-03

Official Correspondent

General Leung

US Agent Details

Nanci Gilmore Business: MIMOSA Diagnostics Inc. Email: nanci@mimosadiagnostics.com Phone: (508) 5793538

Related Public Records

Same Entity

MIMOSA Diagnostics 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
K201432	Masimo Corporation	Masimo O3 Regional Oximeter System	2020-08-29
K211561	Covidien, LLC	INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)	2021-12-05

Similar Registrations

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3009673645	SOTERA WIRELESS	Carlsbad, CA, US
3010611950	Natus Neurology Incorporated	Middleton, WI, US
3004105270	PLEXUS CORP.	BUFFALO GROVE, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021337298. Last updated year: 2026. Please use registration number 3021337298 when referencing this establishment in official correspondence.