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 |