Adjunctive Hemodynamic Indicator With Decision Point For Military Use
An adjunctive hemodynamic indicator with decision point for military use is a cardiovascular device that identifies and monitors hemodynamic conditions of interest, providing clinically meaningful notifications at a defined decision point; it is intended for adjunctive use alongside other monitoring and patient information, specifically for use by the U.S. Military. It is classified as FDA Class II (510(k) required) under regulation 870.2220 in the Cardiovascular specialty, with product code SAR. The device is not an implant and does not support life-sustaining functions.
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Basic Information
- Product Code
- SAR
- Device Class
- FDA class 2
- Regulation Number
- 870.2220
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K233249 | APPRAISE-HRI | Apr 05, 2024 | Substantially Equivalent | The Surgeon General, Department of the Army (TSG-DA) |