K231561 is an FDA 510(k) clearance for the Pulmonary Function Tester, Model: A9. This device is classified as a Calculator, Predicted Values, Pulmonary Function (Class II - Special Controls, product code BTY).
Submitted by Guangzhou Homesun Medical Technology Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on February 21, 2024, 266 days after receiving the submission on May 31, 2023.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1890.
| 510(k) Number | K231561 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 2023 |
| Decision Date | February 21, 2024 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTY - Calculator, Predicted Values, Pulmonary Function |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1890 |