Data / Medical devices / United States / Sleep Science Partners, Inc.
Sleep Science Partners, Inc.: FDA-registered device maker in Larkspur, CA, United States, 3 510(k) clearances
Sleep Science Partners, Inc. is registered with the FDA (registration 3006794225) in Larkspur, CA, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated April 11, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006794225
- Address
- 700 Larkspur Landing Circle Suite 245, Larkspur, CA, United States, 94939
- Owner or operator
- Sleep Science Partners, Inc. (10023348)
- Roles
- Specification developer
- First device listed
- November 19, 2007
- Registered through
- 2026
- Brand names listed
- PureSleep, PureSleep (OTC), PureSleep Pro
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Anti-Snoring | LRK | 2 | 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 |
|---|---|---|---|---|---|---|
| April 11, 2019 | K190058 | PureSleep (OTC use) | LRK | Substantially Equivalent | Sleep Science Partners, Inc. | accessdata.fda.gov |
| June 11, 2012 | K113022 | PURESLEEP | LRK | Substantially Equivalent | Sleep Science Partners, Inc. | accessdata.fda.gov |
| October 2, 1995 | K954128 | SNOREMASTER | LRK | Substantially Equivalent | D.D.S., Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 11, 2019. 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.