AHI System
FDA 510(k) K221203 · Fifth Eye, Inc.
510(k) numberK221203
Submission
- Device name
- AHI System
- Applicant
- Fifth Eye, Inc.
Ann Arbor, MI, US - Received
- April 26, 2022
- Decision date
- July 14, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QNV – Adjunctive Hemodynamic Indicator With Decision Point
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2220
- Specialty
- Cardiovascular
An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information.
Other 510(k)s with product code QNV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212219 | AHI SystemQNV · Traditional | Fifth Eye, Inc. | 12/03/2021SE |
More from Fifth Eye, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K212219 | AHI SystemQNV · Traditional | 12/03/2021SE |
Questions and answers
When was AHI System cleared by the FDA?
AHI System (K221203) received a 510(k) decision of Substantially Equivalent on July 14, 2022, 79 days after the submission was received.
What is the product code of K221203?
The FDA product code is QNV – Adjunctive Hemodynamic Indicator With Decision Point, a Class II (moderate risk) device regulated under 21 CFR 870.2220.