K230386 is an FDA 510(k) clearance for the SpassageQ. This device is classified as a Multivariate Vital Signs Index (Class II - Special Controls, product code PLB).
Submitted by Spass, Inc. (Seoul, KR). The FDA issued a Cleared decision on June 15, 2023, 121 days after receiving the submission on February 14, 2023.
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 | K230386 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 2023 |
| Decision Date | June 15, 2023 |
| Days to Decision | 121 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. |