K233216 is an FDA 510(k) clearance for the CLEWICU System. This device is classified as a Medium-term Adjunctive Predictive Cardiovascular Indicator (Class II - Special Controls, product code QNL).
Submitted by Clew Medical , Ltd. (Poleg, IL). The FDA issued a Cleared decision on January 13, 2024, 107 days after receiving the submission on September 28, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2210. 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..
| 510(k) Number | K233216 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2023 |
| Decision Date | January 13, 2024 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QNL - Medium-term Adjunctive Predictive Cardiovascular Indicator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2210 |
| Definition | 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. |