The following data is part of a premarket notification filed by Respiratory Motion Inc. with the FDA for Exspiron 1xi.
| Device ID | K162131 |
| 510k Number | K162131 |
| Device Name: | ExSpiron 1Xi |
| Classification | Spirometer, Monitoring (w/wo Alarm) |
| Applicant | Respiratory Motion Inc. 411 Waverly Oaks Road, Building 1, Suite 150 Waltham, MA 02452 |
| Contact | Edwin Rule |
| Correspondent | Edwin Rule Respiratory Motion Inc. 411 Waverly Oaks Road, Building 1, Suite 150 Waltham, MA 02452 |
| Product Code | BZK |
| CFR Regulation Number | 868.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-01 |
| Decision Date | 2017-05-09 |
| Summary: | summary |