DYMEDIX DIAGNOSTICS INC

FDA Device Registration & Listing · Shoreview, MN, US · Registration 3009351773

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009351773
FEI Number
3009351773
Entity Name
DYMEDIX DIAGNOSTICS INC
City/State/Country
Shoreview, MN, US
Establishment Address
5985 Rice Creek Pkwy Ste 102, Shoreview, MN 55126, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Dymedix Diagnostics Inc (Owner Number: 10039354)
Owner / Operator Contact Address
5985 Rice Creek Parkway, Suite 102, Shoreview, MN 55126, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K990321
PMA Number
N/A

All Registered Proprietary Names

FlexPro Biopotential Electrodes Disposable Gold Cup EEG Electrodes Monitor, breathing frequency Ventilatory Effort Recorder

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HCC Device, Biofeedback Neurology Class 2 882.5050 2022-12-01
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2023-12-08
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2011-12-30
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2011-12-30

Official Correspondent

Brad Dawson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Dymedix 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
K873418 Bodylog, Inc. BODYLOG STRESS REDUCTION PACKAGE 1987-12-17
K792659 Bio-Feedback Systems, Inc. FEEDBACK EDR SYSTEM MODEL ME-1 1980-01-09
K070612 Top-Rank Health Care Equipment Co., Ltd. TOP-RANK ADHESIVE ELECTRODE 2007-05-07
K123915 Grass Technologies, an Astro-Med, Inc. Product Gro DE48-PLUS 2013-04-24
K073532 Technomed Europe DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES 2008-05-01

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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3005196642 HARMONIC ENERGETIC TECHNOLOGIES, LLC Liverpool, NY, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009351773. Last updated year: 2026. Please use registration number 3009351773 when referencing this establishment in official correspondence.
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