Data / Medical devices / United States / KHN Solutions LLC
KHN Solutions LLC: FDA-registered device maker in San Francisco, CA, United States, 3 510(k) clearances
KHN Solutions LLC is registered with the FDA (registration 3004144955) in San Francisco, CA, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated March 24, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004144955
- Address
- 200 Green Street 2nd floor, San Francisco, CA, United States, 94111
- Owner or operator
- KHN SOLUTIONS, LLC (9058319)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- October 5, 2007
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Devices, Breath Trapping, Alcohol | DJZ | 1 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| March 24, 2009 | K090067 | BACTRACK SELECT BREATHALYZER, MODEL S80 | DJZ | Substantially Equivalent | Khn Solutions, LLC | accessdata.fda.gov |
| September 14, 2007 | K071067 | BACTRACK LCD ALCOHOL DETECTOR | DJZ | Substantially Equivalent | Khn Solutions, LLC | accessdata.fda.gov |
| February 9, 2005 | K043188 | ALCOHAWK PRECISION | DJZ | Substantially Equivalent | Q3 Innovations, LLC | accessdata.fda.gov |
Compare with other makers
Updated March 24, 2009. 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.