Data / Medical devices / United States / Medeia Inc
Medeia Inc: FDA-registered device maker in Santa Barbara, CA, United States, 8 510(k) clearances
Medeia Inc is registered with the FDA (registration 3010536822) in Santa Barbara, CA, United States. It lists 14 device types. The FDA files 8 510(k) clearances under its listings, the newest dated January 28, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010536822
- Address
- 7 W. Figueroa Street, Suite 215, Santa Barbara, CA, United States, 93101
- Owner or operator
- Medeia Inc (10045108)
- Roles
- Repackager or relabeler
- First device listed
- October 21, 2013
- Registered through
- 2026
- Brand names listed
- ANSHA - QHRV1, BrainView, BrainView QEEG, CardioView, Critical Care Assessment, NeuralScan System, QBioscan, QHRV1 and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| January 28, 2023 | K212684 | BrainView QEEG Software | OLU | Substantially Equivalent | Medeia, Inc. | accessdata.fda.gov |
| March 17, 2020 | K192753 | NeuralScan System | GWQ | Substantially Equivalent | Medeia, Inc. | accessdata.fda.gov |
| January 15, 2020 | K191266 | VitalScan ANS | JOM | Substantially Equivalent | Medeia, Inc. | accessdata.fda.gov |
| April 29, 2016 | K152973 | Dyna-Vision Telemonitoring System | MHX | Substantially Equivalent | Techmedic Development International B.V. | accessdata.fda.gov |
| October 19, 2015 | K150804 | QBioScan | GZO | Substantially Equivalent | Medeia, Inc. | accessdata.fda.gov |
| September 21, 2010 | K101983 | CRITICAL CARE ASSESSMENT | JOM | Substantially Equivalent | Critical Patient Care, Inc. | accessdata.fda.gov |
| February 18, 2009 | K083735 | ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS | JOM | Substantially Equivalent | Medtechs, LLC | accessdata.fda.gov |
| April 11, 2008 | K080884 | QHRV 1 - HEALTH ASSESSMENT SYSTEM | DPS | Substantially Equivalent | Medtechs, LLC | accessdata.fda.gov |
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Updated January 28, 2023. 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.