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Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K212071
510(k) Type
Traditional
Applicant
CEFALY Technology
Country
Belgium
FDA Decision
Substantially Equivalent
Decision Date
12/13/2022
Days to Decision
529 days
Submission Type
Summary

Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K212071
510(k) Type
Traditional
Applicant
CEFALY Technology
Country
Belgium
FDA Decision
Substantially Equivalent
Decision Date
12/13/2022
Days to Decision
529 days
Submission Type
Summary