K232495 is an FDA 510(k) clearance for the Sempulse Halo Vital Signs Monitor. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Sempulse Corporation (San Marcos, US). The FDA issued a Cleared decision on May 16, 2024, 273 days after receiving the submission on August 17, 2023.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K232495 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 2023 |
| Decision Date | May 16, 2024 |
| Days to Decision | 273 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | DQA - Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |