The following data is part of a premarket notification filed by Cleerly Inc with the FDA for Cleerly Labs.
| Device ID | K190868 |
| 510k Number | K190868 |
| Device Name: | Cleerly Labs |
| Classification | System, Image Processing, Radiological |
| Applicant | Cleerly Inc 101 Greenwich St, Suite 11C New York, NY 10006 |
| Contact | Kimberly Elmore |
| Correspondent | Kimberly Elmore Cleerly Inc 101 Greenwich St, Suite 11C New York, NY 10006 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-03 |
| Decision Date | 2019-11-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001924114 | K190868 | 000 |