DEN200022 is an FDA 510(k) submission for the Analytic for Hemodynamic Instability (AHI). 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 Not Cleared (DENG) decision on March 1, 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 | DEN200022 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | April 03, 2020 |
| Decision Date | March 01, 2021 |
| Days to Decision | 332 days |
| Submission Type | Direct |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| 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. |