The following data is part of a premarket notification filed by Fifth Eye Inc. with the FDA for Ahi System.
| Device ID | K212219 |
| 510k Number | K212219 |
| 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 A. Baird |
| Correspondent | Donna-bea Tillman Biologics Consulting Group 1555 King Street, Suite 300 Alexandria, VA 22314 |
| Product Code | QNV |
| CFR Regulation Number | 870.2220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-16 |
| Decision Date | 2021-12-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B823AHIV200 | K212219 | 000 |