SPEAC System— 510(k) K182180
Substantially EquivalentBrain Sentinel, Inc.
FDA 510(k) clearance K182180 for SPEAC System, Substantially Equivalent on 2019-05-11. Applicant: Brain Sentinel, Inc.. Device class: 2.
Clearance details
- Applicant
- Brain Sentinel, Inc.
- Product code
- Code POS
- Device class
- Class 2
- Regulation
- 21 CFR 882.1580
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Antonio, TX, US
Recent devices under product code POS
view allMore clearances from Brain Sentinel, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.