The following data is part of a premarket notification filed by Sigma Scientific Services Llc with the FDA for Medilab.
| Device ID | K221065 |
| 510k Number | K221065 |
| Device Name: | MediLab |
| Classification | System, Image Processing, Radiological |
| Applicant | Sigma Scientific Services LLC 7737 N University Drive, Suite 101 Tamarac, FL 33321 |
| Contact | Jorge Millan |
| Correspondent | Jorge Millan Sigma Scientific Services LLC 7737 N University Drive, Suite 101 Tamarac, FL 33321 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-12 |
| Decision Date | 2022-06-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MEDILAB 73475305 not registered Dead/Abandoned |
Technology Communications, Ltd. 1984-04-13 |