Adjunctive Open Loop Fluid Therapy Recommender
The Adjunctive Open Loop Fluid Therapy Recommender is a prescription software device that uses algorithms to analyze cardiovascular vital signs and predict a patient's estimated response to fluid therapy, intended for adjunctive use alongside other physical vital sign parameters and patient information. It is not intended to independently direct therapy. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 870.5600 in the Cardiovascular specialty. It carries product code QMS and is eligible for third-party review. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QMS
- Device Class
- FDA class 2
- Regulation Number
- 870.5600
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
The adjunctive open loop fluid therapy recommender is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict a patients estimated response to fluid therapy. The device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.