Adjunctive Hemodynamic Indicator With Decision Point For Military Use
SAR is the FDA product code for Adjunctive Hemodynamic Indicator With Decision Point For Military Use, a class II device type, regulated under 21 CFR 870.2220. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- SAR
- Device name
- Adjunctive Hemodynamic Indicator With Decision Point For Military Use
- FDA 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.
- Regulation
- 21 CFR 870.2220
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code SAR
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2024 | 1 |
Applicants with the most clearances
Product code SAR| Applicant | Clearances |
|---|---|
| The Surgeon General, Department of the Army (TSG-DA) | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code SAR.
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