K240756 is an FDA 510(k) clearance for the AITRICS-VC. This device is classified as a Multivariate Vital Signs Index (Class II - Special Controls, product code PLB).
Submitted by Aitrics Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on July 23, 2024, 125 days after receiving the submission on March 20, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300. Automated Calculation Of A Summary Index (or Indices) Based On Several Individual Measured Vital Sign Inputs..
| 510(k) Number | K240756 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2024 |
| Decision Date | July 23, 2024 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | PLB - Multivariate Vital Signs Index |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2300 |
| Definition | Automated Calculation Of A Summary Index (or Indices) Based On Several Individual Measured Vital Sign Inputs. |