Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K183646
Acumen Hypotension Prediction Index EV1000 Clinical Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform - Pressure · Edwards Lifeciences, LLC · decided 2019-05-21 (SESE)
FDA 510(k) database ↗Summary PDF ↗
No GUDID device is registered under this submission yet — registration typically lags clearance by months.
Devices
No matching devices.
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