SAR — Adjunctive Hemodynamic Indicator With Decision Point For Military Use Class II
FDA product code SAR covers "Adjunctive Hemodynamic Indicator With Decision Point For Military Use", a Class II medical device regulated under 21 CFR 870.2220. Submissions are reviewed by the Cardiovascular panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SAR
- Device Class
- Class II
- Regulation Number
- 870.2220
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233249 | surgeon general, department of the army (tsg-da) | APPRAISE-HRI | April 5, 2024 |