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 |