K212219 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 December 3, 2021, 140 days after receiving the submission on July 16, 2021.
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 | K212219 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 2021 |
| Decision Date | December 03, 2021 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| 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. |