K183646 is an FDA 510(k) clearance for the Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure. This device is classified as a Adjunctive Predictive Cardiovascular Indicator (Class II - Special Controls, product code QAQ).
Submitted by Edwards Lifeciences, LLC (Irvine, US). The FDA issued a Cleared decision on May 21, 2019, 146 days after receiving the submission on December 26, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2210. The Adjunctive Predictive Cardiovascular Indicator Is A Prescription Device That Uses Software Algorithms To Analyze Cardiovascular Vital Signs And Predict Future Cardiovascular Status Or Events. This Device Is Intended For Adjunctive Use With Other Physical Vital Sign Parameters And Patient Information And Is Not Intended To Independently Direct Therapy..
| 510(k) Number | K183646 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2018 |
| Decision Date | May 21, 2019 |
| Days to Decision | 146 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QAQ - Adjunctive Predictive Cardiovascular Indicator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2210 |
| Definition | The Adjunctive Predictive Cardiovascular Indicator Is A Prescription Device That Uses Software Algorithms To Analyze Cardiovascular Vital Signs And Predict Future Cardiovascular Status Or Events. This Device Is Intended For Adjunctive Use With Other Physical Vital Sign Parameters And Patient Information And Is Not Intended To Independently Direct Therapy. |