K221203 is an FDA 510(k) clearance for the AHI System. This device is classified as a Adjunctive Hemodynamic Indicator With Decision Point (Class II - Special Controls, product code QNV).
Submitted by Fifth Eye, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on July 14, 2022, 79 days after receiving the submission on April 26, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2220. 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..
| 510(k) Number | K221203 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2022 |
| Decision Date | July 14, 2022 |
| Days to Decision | 79 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QNV - Adjunctive Hemodynamic Indicator With Decision Point |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2220 |
| Definition | 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. |