The following data is part of a premarket notification filed by Lucid Diagnostics, Inc. with the FDA for Esocheck Cell Collection Device.
| Device ID | K210137 |
| 510k Number | K210137 |
| Device Name: | EsoCheck Cell Collection Device |
| Classification | Esophagoscope (flexible Or Rigid) |
| Applicant | Lucid Diagnostics, Inc. One Grand Central Place, Suite 4600 New York, NY 10165 |
| Contact | Lishan Aklog |
| Correspondent | Janice Hogan Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, PA 19103 |
| Product Code | EOX |
| CFR Regulation Number | 874.4710 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-19 |
| Decision Date | 2021-02-18 |