FDA Product Code SAR: Adjunctive Hemodynamic Indicator With Decision Point For Military Use
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.
Leading manufacturers include The Surgeon General, Department of the Army (TSG-DA).
FDA 510(k) Cleared Adjunctive Hemodynamic Indicator With Decision Point For Military Use Devices (Product Code SAR)
About Product Code SAR - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SAR since 2024, with 1 receiving FDA clearance (average review time: 190 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
SAR devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →