SAR
- Product code
- SAR
- Device name
- Adjunctive Hemodynamic Indicator With Decision Point For Military Use
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.2220
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 1 (all years; only the last 3 years are listed here)
FDA classification 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) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K233249 | 2024-04-05 | The Surgeon General, Department of the… | APPRAISE-HRI |
Official FDA classification page: SAR
Classification and pathway per current FDA publications. Data from openFDA (CC0).