Data / Medical devices / United States / Serena Sleep
Serena Sleep: FDA-registered device maker in Hudson, WI, United States, 2 510(k) clearances
Serena Sleep is registered with the FDA (registration 3018783197) in Hudson, WI, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 13, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018783197
- Address
- 592 Outpost Cir Ste H, Hudson, WI, United States, 54016
- Owner or operator
- Serena Sleep (10081481)
- Roles
- Manufacturer
- First device listed
- April 19, 2021
- Registered through
- 2026
- Brand names listed
- Serena Sleep Ace, Serena Sleep Elevate, Serena Sleep Night Guard
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Anti-Snoring | LRK | 2 | Manufacturer | accessdata.fda.gov |
| Mouthguard, Migraine/Tension Headache | OCO | U | Manufacturer | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | 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 |
|---|---|---|---|---|---|---|
| October 13, 2023 | K230495 | Serena Sleep Night Guard | MQC | Substantially Equivalent | Meris Investment Group | accessdata.fda.gov |
| March 10, 2021 | K203606 | Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) | LRK | Substantially Equivalent | Meris Investment Group | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Anti-Snoring
- All makers of Mouthguard, Migraine/Tension Headache
- All makers of Mouthguard, Prescription
Updated October 13, 2023. 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.