CEFALY
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
STX-MED SPRL
The following data is part of a De Novo classification by Stx-med Sprl with the FDA for Cefaly.
Pre-market Notification Details
| DeNovo ID | DEN120019 |
| Device Name: | CEFALY |
| Classification | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine |
| Applicant | STX-MED SPRL zi Des Haunts Sarts 4e Avenue 5 Herstal, Liege, BE 4040 |
| Contact | Jean-yves Mignolet |
| Product Code | PCC |
| CFR Regulation Number | 882.5891 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K122566 |
| Review Advisory Board | Neurology |
| Classification Advisory | Neurology |
| Type | Post-NSE |
| Date Received | 2012-12-13 |
| Decision Date | 2014-03-11 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
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