K231586 is an FDA 510(k) clearance for the Endophys Blood Pressure Monitor model BPM-30. This device is classified as a Computer, Blood-pressure (Class II - Special Controls, product code DSK).
Submitted by Endophys Technologies, LLC (Dallas, US). The FDA issued a Cleared decision on November 3, 2023, 156 days after receiving the submission on May 31, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1110.
| 510(k) Number | K231586 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 2023 |
| Decision Date | November 03, 2023 |
| Days to Decision | 156 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSK - Computer, Blood-pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1110 |