Data / Medical devices / United States / Apnomed, Inc.
Apnomed, Inc.: FDA-registered device maker in Bellevue, WA, United States, 1 510(k) clearance
Apnomed, Inc. is registered with the FDA (registration 3017092365) in Bellevue, WA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 21, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017092365
- Address
- 12715 NE Bel-Red Rd. Suite #140, Bellevue, WA, United States, 98005
- Owner or operator
- Apnomed, Inc. (10056822)
- Roles
- Specification developer
- First device listed
- July 2, 2020
- Registered through
- 2026
- Brand names listed
- ApnoDent appliance, ApnoMed TEEN, ApnoTx Orthodontic Appliance, DAMES Distraction Assisted Mandibular Expander, MAPE Micro-Implant Assisted Protractor Expander
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Anti-Snoring | LRK | 2 | Specification developer | accessdata.fda.gov |
| Device, Jaw Repositioning | LQZ | 2 | Specification developer | accessdata.fda.gov |
| Retainer, Screw Expansion, Orthodontic | DYJ | 1 | 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 |
|---|---|---|---|---|---|---|
| November 21, 2018 | K181123 | ApnoDent Appliance | LRK | Substantially Equivalent | Apnomed, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Retainer, Screw Expansion, Orthodontic
- All makers of Device, Jaw Repositioning
- All makers of Device, Anti-Snoring
Updated November 21, 2018. 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.