Data / Medical devices / United States / Spark Neuro, Inc.
Spark Neuro, Inc.: FDA-registered device maker in New York, NY, United States, 1 510(k) clearance
Spark Neuro, Inc. is registered with the FDA (registration 3029984080) in New York, NY, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 18, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029984080
- Address
- 224 W 35th St Ste 500 # 2031, New York, NY, United States, 10001
- Owner or operator
- Spark Neuro, Inc. (10089104)
- Roles
- Manufacturer
- First device listed
- November 6, 2023
- Registered through
- 2026
- Brand names listed
- SPARK Neuro Cognitive Assessment Aid, SPARK Scan
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computerized Cognitive Assessment Aid, Exempt | PTY | 2 | Manufacturer | accessdata.fda.gov |
| Full-Montage Standard Electroencephalograph | GWQ | 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 |
|---|---|---|---|---|---|---|
| August 18, 2023 | K231457 | SPARK Scan | GWQ | Substantially Equivalent | Spark Neuro, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Full-Montage Standard Electroencephalograph
- All makers of Computerized Cognitive Assessment Aid, Exempt
Updated August 18, 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.