The following data is part of a premarket notification filed by Cefaly Technology with the FDA for Cefaly.
Device ID | K160237 |
510k Number | K160237 |
Device Name: | Cefaly |
Classification | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine |
Applicant | CEFALY TECHNOLOGY ZI DES HAUTS SARTS, 4EME AVENUE 5 Herstal, BE 4040 |
Contact | Jean-yves Mignolet |
Correspondent | Jean-yves Mignolet CEFALY TECHNOLOGY ZI DES HAUTS SARTS, 4EME AVENUE 5 Herstal, BE 4040 |
Product Code | PCC |
CFR Regulation Number | 882.5891 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-02-01 |
Decision Date | 2016-03-04 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05425018850129 | K160237 | 000 |
05425018850150 | K160237 | 000 |
05425018850143 | K160237 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CEFALY 87924056 not registered Live/Pending |
CEFALY Technology 2018-05-16 |
CEFALY 79053734 3647710 Live/Registered |
CEFALY Technology 2008-04-28 |