K213423 is an FDA 510(k) clearance for the T3 Platform software. This device is classified as a Multivariate Vital Signs Index (Class II - Special Controls, product code PLB).
Submitted by Etiometry, Inc. (Boston, US). The FDA issued a Cleared decision on January 6, 2023, 443 days after receiving the submission on October 20, 2021.
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 | K213423 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 2021 |
| Decision Date | January 06, 2023 |
| Days to Decision | 443 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. |