K161534 is an FDA 510(k) clearance for the EasyOne Pro Respiratory Analysis System. This device is classified as a Calculator, Predicted Values, Pulmonary Function (Class II - Special Controls, product code BTY).
Submitted by Ndd Medizintechnik AG (Zurich, CH). The FDA issued a Cleared decision on February 22, 2017, 264 days after receiving the submission on June 3, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1890.
| 510(k) Number | K161534 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 2016 |
| Decision Date | February 22, 2017 |
| Days to Decision | 264 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 |