Data / Medical devices / United States / Monitored Therapeutics, Inc.
Monitored Therapeutics, Inc.: FDA-registered device maker in Dublin, OH, United States, 3 510(k) clearances
Monitored Therapeutics, Inc. is registered with the FDA (registration 3012250536) in Dublin, OH, United States. It lists 8 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 4, 2020. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3012250536
- Address
- 5160 Blazer Parkway, Dublin, OH, United States, 43017
- Owner or operator
- Monitored Therapeutics, Inc. (10050970)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- January 21, 2016
- Registered through
- 2026
- Brand names listed
- 6MWT Six Minute Walk Test, Adapter, 22mm OD to 22mm OD, Adapter, 30mm ID to 22mm OD, CliniSphere, GoClinic, GoClinic 6MWT, GoECG, GoFeNo and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clip, Nose | BXJ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Connector, Airway (Extension) | BZA | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Device, Rebreathing | BYW | 1 | Complaint file establishment | accessdata.fda.gov |
| Electrocardiograph | DPS | 2 | Complaint file establishment | accessdata.fda.gov |
| Mask, Oxygen, Non-Rebreathing | KGB | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Mouthpiece, Breathing | BYP | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Spirometer, Diagnostic | BZG | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| December 4, 2020 | K202837 | GoSpiro | BZG | Substantially Equivalent | Monitored Therapeutics, Inc. | accessdata.fda.gov |
| December 28, 2018 | K183369 | COR12 ECG | DPS | Substantially Equivalent | Corscience GmbH & Co. | accessdata.fda.gov |
| March 24, 2017 | K163249 | GoSpiro | BZG | Substantially Equivalent | Monitored Therapeutics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Spirometer, Diagnostic
- All makers of Device, Rebreathing
- All makers of Mask, Oxygen, Non-Rebreathing
- All makers of Medical Device Data System
- All makers of Electrocardiograph
- All makers of Clip, Nose
Updated December 4, 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.