The following data is part of a premarket notification filed by Visibly, Inc. with the FDA for Visibly Digital Acuity Product.
| Device ID | K220090 |
| 510k Number | K220090 |
| Device Name: | Visibly Digital Acuity Product |
| Classification | Digital Visual Acuity Test |
| Applicant | Visibly, Inc. 207 E Ohio Street, #233 Chicago, IL 60611 |
| Contact | Paul Foley |
| Correspondent | Janice M. Hogan Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, PA 19103 |
| Product Code | QTO |
| CFR Regulation Number | 886.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-11 |
| Decision Date | 2022-08-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850038376000 | K220090 | 000 |