Adjunctive Hemodynamic Indicator With Decision Point
The Adjunctive Hemodynamic Indicator with Decision Point is a cardiovascular monitoring device that identifies and monitors hemodynamic conditions of interest and provides notifications at clinically meaningful decision points, intended for adjunctive use alongside other monitoring data and patient information. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 870.2220 in the Cardiovascular specialty. It carries product code QNV and is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QNV
- 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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.