1 device · 1 company · 2024
Product code SAR: Adjunctive Hemodynamic Indicator With Decision Point For Military Use
1 device under product code SAR, 2024, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Adjunctive Hemodynamic Indicator With Decision Point For Military Use. 21 CFR 870.2220, Class II. 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. The device is intended for use by the Military. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| APPRAISE-HRIK233249 · 510(k) | The Surgeon General, Department of the Army (TSG-DA) | Cardiovascular | database entry |
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