Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx— 510(k) K212071
Substantially EquivalentCefaly Technology
FDA 510(k) clearance K212071 for Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx, Substantially Equivalent on 2022-12-13. Applicant: Cefaly Technology. Device class: 2.
Clearance details
- Applicant
- Cefaly Technology
- Product code
- Code PCC
- Device class
- Class 2
- Regulation
- 21 CFR 882.5891
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seraing, BE
Recent devices under product code PCC
view allMore clearances from Cefaly Technology
view allAdverse events under product code PCC
product code PCC- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.