510(k) K233253
K233253 is an FDA 510(k) premarket notification submitted by Agilemd, Inc. for the device "eCARTv5 Clinical Deterioration Suite (eCART)". The FDA issued a decision of Substantially Equivalent on June 21, 2024. The device falls under product code QNL (Medium-Term Adjunctive Predictive Cardiovascular Indicator), a Class II device regulated under 21 CFR 870.2210.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 21, 2024
- Date Received
- September 28, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Medium-Term Adjunctive Predictive Cardiovascular Indicator
- Device Class
- Class II
- Regulation Number
- 870.2210
- Review Panel
- CV
- Submission Type
The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events within a defined medium-term period. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.