Data / Medical devices / United States / Cognita Labs LLC
Cognita Labs LLC: FDA-registered device maker in Santa Ana, CA, United States, 2 510(k) clearances
Cognita Labs LLC is registered with the FDA (registration 3017200972) in Santa Ana, CA, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 18, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017200972
- Address
- 700 N Main ST Ste C1, Santa Ana, CA, United States, 92701
- Owner or operator
- Cognita Labs LLC (10076939)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- August 5, 2020
- Registered through
- 2026
- Brand names listed
- CapMedic, PulmoScan
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Impedance Measuring Device Utilizing Oscillation Techniques | PNV | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Spirometer, Monitoring (W/Wo Alarm) | BZK | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| March 18, 2020 | K191876 | PulmoScan | PNV | Substantially Equivalent | Cognita Labs, LLC | accessdata.fda.gov |
| September 13, 2019 | K183586 | CapMedic | CAF | Substantially Equivalent | Cognita Labs, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Impedance Measuring Device Utilizing Oscillation Techniques
- All makers of Spirometer, Monitoring (W/Wo Alarm)
- All makers of Nebulizer (Direct Patient Interface)
Updated March 18, 2020. 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.