The following data is part of a premarket notification filed by Cefaly Technology with the FDA for Cefaly Dual.
| Device ID | K201895 |
| 510k Number | K201895 |
| Device Name: | Cefaly Dual |
| Classification | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine |
| Applicant | CEFALY Technology Rue Louis Plescia 34 Seraing, BE 4102 |
| Contact | Rufus Kay Moberly |
| Correspondent | Parul Chansoria Elexes Medical Consulting 6494 Tralee Village Dr Dublin, CA 94568 |
| Product Code | PCC |
| CFR Regulation Number | 882.5891 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-08 |
| Decision Date | 2020-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05425018850273 | K201895 | 000 |