Data / Medical devices / United States / MDL Solutions Incorporated
MDL Solutions Incorporated: FDA-registered device maker in Hamel, MN, United States, 1 510(k) clearance
MDL Solutions Incorporated is registered with the FDA (registration 3025434453) in Hamel, MN, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 15, 2002. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025434453
- Address
- 705 Tower Drive, Hamel, MN, United States, 55340
- Owner or operator
- MDL Solutions Incorporated (10086686)
- Roles
- Manufacturer
- First device listed
- December 2, 2022
- Registered through
- 2026
- Brand names listed
- Emergent, Porto2 Vent Emergency CPAP
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | 2 | Manufacturer | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Manufacturer | accessdata.fda.gov |
| Ventilator, Emergency, Powered (Resuscitator) | BTL | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| July 15, 2002 | K021520 | EMT-CPAP | BTL | Substantially Equivalent | Emergency Medical Techology | accessdata.fda.gov |
Compare with other makers
- All makers of Attachment, Breathing, Positive End Expiratory Pressure
- All makers of Ventilator, Emergency, Powered (Resuscitator)
- All makers of Mask, Oxygen
Updated July 15, 2002. 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.