510(k) K241479
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 2025
- Date Received
- May 24, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adjunctive Cardiovascular Status Indicator
- Device Class
- Class II
- Regulation Number
- 870.2200
- Review Panel
- CV
- Submission Type
The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.