Data / Medical devices / United States / REMware
REMware: FDA-registered device maker in Tampa, FL, United States, 1 510(k) clearance
REMware is registered with the FDA (registration 3016939722) in Tampa, FL, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 4, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016939722
- Address
- 601 S Harbour Island Blvd Ste 109, Tampa, FL, United States, 33602
- Owner or operator
- Somnomed Technologies, Inc. (10084979)
- Roles
- Manufacturer
- First device listed
- March 24, 2025
- Registered through
- 2026
- Brand names listed
- DreamClear
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Amplifier, Physiological Signal | GWL | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Manufacturer | accessdata.fda.gov |
| Ventilatory Effort Recorder | MNR | 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 |
|---|---|---|---|---|---|---|
| September 4, 2024 | K240646 | DreamClear | GWL | Substantially Equivalent | Somnomed Technologies Inc., Doing Business AS Remware | accessdata.fda.gov |
Compare with other makers
- All makers of Oximeter
- All makers of Ventilatory Effort Recorder
- All makers of Amplifier, Physiological Signal
Updated September 4, 2024. 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.