SPARK Scan— 510(k) K231457
Substantially EquivalentSpark Neuro, Inc.
FDA 510(k) clearance K231457 for SPARK Scan, Substantially Equivalent on 2023-08-18. Applicant: Spark Neuro, Inc.. Device class: 2.
Clearance details
- Applicant
- Spark Neuro, Inc.
- Product code
- Code GWQ
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
Recent devices under product code GWQ
view allData sourced from openFDA. This site is unofficial and independent of the FDA.