K152258 is an FDA 510(k) clearance for the T3 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 March 31, 2016, 233 days after receiving the submission on August 11, 2015.
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 | K152258 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 2015 |
| Decision Date | March 31, 2016 |
| Days to Decision | 233 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. |