510(k) K200717
K200717 is an FDA 510(k) premarket notification submitted by Clew Medical , Ltd. for the device "CLEWICU System (ClewICUServer and ClewICUnitor)". The FDA issued a decision of Substantially Equivalent on January 9, 2021. The device falls under product code QNL (Medium-Term Adjunctive Predictive Cardiovascular Indicator), a Class II device regulated under 21 CFR 870.2210. Clew Medical , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 2021
- Date Received
- March 18, 2020
- 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.