K173937 is an FDA 510(k) clearance for the SpiroSphere. 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 February 15, 2019, 416 days after receiving the submission on December 26, 2017.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1890.
| 510(k) Number | K173937 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2017 |
| Decision Date | February 15, 2019 |
| Days to Decision | 416 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 |