K183282 is an FDA 510(k) clearance for the Biovitals Analytics Engine. This device is classified as a Multivariate Vital Signs Index (Class II - Special Controls, product code PLB).
Submitted by Biofourmis Singapore Pte., Ltd. (Singapore, SG). The FDA issued a Cleared decision on August 15, 2019, 262 days after receiving the submission on November 26, 2018.
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 | K183282 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 2018 |
| Decision Date | August 15, 2019 |
| Days to Decision | 262 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. |