Data / Medical devices / United States / Snap Diagnostics, L.L.C.
Snap Diagnostics, L.L.C.: FDA-registered device maker in Vernon Hills, IL, United States, 3 510(k) clearances
Snap Diagnostics, L.L.C. is registered with the FDA (registration 1423640) in Vernon Hills, IL, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated June 4, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1423640
- FEI number
- 3000215335
- Address
- 616 Atrium Drive Suite 100, Vernon Hills, IL, United States, 60061
- Owner or operator
- SNAP Diagnostics (9016339)
- Roles
- Manufacturer
- First device listed
- November 9, 2011
- Registered through
- 2027
- Brand names listed
- Model 7, Model 8, SAM Sleep Apnea Device Model 9-1000
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| June 4, 2024 | K240100 | SAM Model 9-10000 | MNR | Substantially Equivalent | Snap Diagnostics, LLC | accessdata.fda.gov |
| March 18, 2011 | K110064 | SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM | MNR | Substantially Equivalent | Snap Diagnostics, LLC | accessdata.fda.gov |
| May 23, 2008 | K080321 | SNAP MODEL 7 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM | MNR | Substantially Equivalent | Snap Laboratories, LLC | accessdata.fda.gov |
Compare with other makers
Updated June 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.