510(k) K230842
K230842 is an FDA 510(k) premarket notification submitted by Implicity, Inc. for the device "SignalHF (IM008)". The FDA issued a decision of Substantially Equivalent on October 25, 2023. The device falls under product code QNL (Medium-Term Adjunctive Predictive Cardiovascular Indicator), a Class II device regulated under 21 CFR 870.2210. Implicity, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 25, 2023
- Date Received
- March 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.