The following data is part of a premarket notification filed by Onefit Medical with the FDA for Hipeos.
Device ID | K161479 |
510k Number | K161479 |
Device Name: | HipEOS |
Classification | System, Image Processing, Radiological |
Applicant | ONEFIT MEDICAL 18 RUE ALAIN SAVARY Besancon, FR 25000 |
Contact | Julien Simon |
Correspondent | Julien Simon ONEFIT MEDICAL 18 RUE ALAIN SAVARY Besancon, FR 25000 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-05-31 |
Decision Date | 2016-06-28 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HIPEOS 79313158 not registered Live/Pending |
EOS IMAGING 2021-04-13 |