The following data is part of a premarket notification filed by F Care Systems Usa Llc with the FDA for Med Rf 4000.
Device ID | K210077 |
510k Number | K210077 |
Device Name: | MED RF 4000 |
Classification | Electrosurgical Coagulation For Aesthetic |
Applicant | F Care Systems USA LLC 11098 Biscayne BLVD Suite 301 Miami, FL 33161 |
Contact | Patrick Danciu |
Correspondent | Patrick Danciu F Care Systems USA LLC 11098 Biscayne BLVD Suite 301 Miami, FL 33161 |
Product Code | ONQ |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-01-12 |
Decision Date | 2021-12-17 |