Product Classification

• Device: adjunctive hemodynamic indicator with decision point for military use
• Regulation Description: Adjunctive hemodynamic indicator with decision point.
• 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. The device is intended for use by the Military.
• Physical State: Uses analysis of patient data and/or measured vital signs to detect current signs of a hemodynamic condition.
• Technical Method: Software
• Target Area: Cardiovascular system
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: SAR
• Premarket Review: Office of Cardiovascular Devices (OHT2); Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
• Submission Type: 510(k)
• Regulation Number: 870.2220
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible