Device Classification Name |
Massager, Vacuum, Radio Frequency Induced Heat
|
510(k) Number |
K200359 |
Device Name |
NuEra Tight, NuEra Tight EMS |
Applicant |
Bios s.r.l. |
Via Guido Rossa 10/12 |
Vimodrone,
IT
20090
|
|
Applicant Contact |
Maurizio Bianchi |
Correspondent |
Bios s.r.l. |
Via Guido Rossa 10/12 |
Vimodrone,
IT
20090
|
|
Correspondent Contact |
Maurizio Bianchi |
Regulation Number | 878.4400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/13/2020 |
Decision Date | 08/11/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|