Data / Medical devices / United States / Dymedix Diagnostics Inc
Dymedix Diagnostics Inc: FDA-registered device maker in Shoreview, MN, United States, 6 510(k) clearances
Dymedix Diagnostics Inc is registered with the FDA (registration 3009351773) in Shoreview, MN, United States. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated January 21, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009351773
- Address
- 5985 Rice Creek Pkwy Ste 102, Shoreview, MN, United States, 55126
- Owner or operator
- Dymedix Diagnostics Inc (10039354)
- Roles
- Specification developer
- First device listed
- December 30, 2011
- Registered through
- 2026
- Brand names listed
- Disposable Gold Cup EEG Electrodes, FlexPro Biopotential Electrodes, Monitor breathing frequency, Monitor, breathing frequency, Ventilatory Effort Recorder
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Biofeedback | HCC | 2 | Specification developer | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Specification developer | accessdata.fda.gov |
| Monitor, Breathing Frequency | BZQ | 2 | Specification developer | accessdata.fda.gov |
| Ventilatory Effort Recorder | MNR | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 21, 2020 | K192564 | Disposable Gold Cup EEG Electrodes | GXY | Substantially Equivalent | Dymedix Diagnostics, Inc. | accessdata.fda.gov |
| May 5, 2004 | K040069 | DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR | MNR | Substantially Equivalent | Dymedix, Inc. | accessdata.fda.gov |
| April 26, 2004 | K040605 | DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100 | BZQ | Substantially Equivalent | Dymedix, Inc. | accessdata.fda.gov |
| April 16, 2002 | K020468 | CHIN ELECTRODE | GXY | Substantially Equivalent | Dymedix, Inc. | accessdata.fda.gov |
| May 11, 2000 | K001030 | RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, MODEL 3000S | BZQ | Substantially Equivalent | Dymedix, Inc. | accessdata.fda.gov |
| June 1, 1999 | K990321 | ALPHAMED GEMINI SENSOR, SNORING SENSOR | MNR | Substantially Equivalent | Alphamed, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Cutaneous
- All makers of Device, Biofeedback
- All makers of Ventilatory Effort Recorder
- All makers of Monitor, Breathing Frequency
Updated January 21, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.