K223629 is an FDA 510(k) clearance for the SpiroSphere, SpiroSphereECG, CardioSphere. This device is classified as a Calculator, Predicted Values, Pulmonary Function (Class II - Special Controls, product code BTY).
Submitted by Eresearchtechnology GmbH (Estenfeld, DE). The FDA issued a Cleared decision on May 28, 2024, 540 days after receiving the submission on December 5, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 868.1890.
| 510(k) Number | K223629 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 2022 |
| Decision Date | May 28, 2024 |
| Days to Decision | 540 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | BTY - Calculator, Predicted Values, Pulmonary Function |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1890 |