510(k) K233249
K233249 is an FDA 510(k) premarket notification submitted by The Surgeon General, Department of the Army (TSG-DA) for the device "APPRAISE-HRI". The FDA issued a decision of Substantially Equivalent on April 5, 2024. The device falls under product code SAR (Adjunctive Hemodynamic Indicator With Decision Point For Military Use), a Class II device regulated under 21 CFR 870.2220. The Surgeon General, Department of the Army (TSG-DA) has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 5, 2024
- Date Received
- September 28, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adjunctive Hemodynamic Indicator With Decision Point For Military Use
- Device Class
- Class II
- Regulation Number
- 870.2220
- Review Panel
- CV
- Submission Type
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.