Data / Medical devices / United States / Neko Health Manufacturing LLC
Neko Health Manufacturing LLC: FDA-registered device maker in Englewood, CO, United States, 1 510(k) clearance
Neko Health Manufacturing LLC is registered with the FDA (registration 3004215265) in Englewood, CO, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 26, 2003. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004215265
- Address
- 6500 S Quebec St Ste 210, Englewood, CO, United States, 80111
- Owner or operator
- Neko Health Manufacturing LLC (10096282)
- Roles
- Manufacturer
- First device listed
- August 20, 2026
- Registered through
- 2026
- Brand names listed
- Neko Stethoscope, Thinklabs One
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stethoscope, Electronic | DQD | 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 |
|---|---|---|---|---|---|---|
| November 26, 2003 | K032230 | RHYTHM DIGITAL ELECTRONIC STETHOSCOPE | DQD | Substantially Equivalent | Thinklabs, Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 26, 2003. 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.