The following data is part of a premarket notification filed by Fifth Eye Inc. with the FDA for Ahi System.
| Device ID | K221203 |
| 510k Number | K221203 |
| Device Name: | AHI System |
| Classification | Adjunctive Hemodynamic Indicator With Decision Point |
| Applicant | Fifth Eye Inc. 110 Miller Avenue, Suite 300 Ann Arbor, MI 48104 |
| Contact | Jennifer Baird |
| Correspondent | Donna-Bea Tillman Biologics Consulting 1555 King Street, Suite 300 Alexandria, VA 22314 |
| Product Code | QNV |
| CFR Regulation Number | 870.2220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-26 |
| Decision Date | 2022-07-14 |