The following data is part of a premarket notification filed by Ndd Medizintechnik Ag with the FDA for Easyone Pro Respiratory Analysis System.
| Device ID | K161534 |
| 510k Number | K161534 |
| Device Name: | EasyOne Pro Respiratory Analysis System |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| Applicant | NDD MEDIZINTECHNIK AG TECHNOPARKSTRASSE 1 Zurich, CH 8005 |
| Contact | N/a N/a |
| Correspondent | Jerry Masiello NDD MEDICAL TECHNOLOGIES INC. 300 BRICKSTONE SQUARE SUITE 604 Andover, MA 01810 |
| Product Code | BTY |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-03 |
| Decision Date | 2017-02-22 |
| Summary: | summary |