The following data is part of a premarket notification filed by Respiratory Motion with the FDA for Exspiron 2xi.
| Device ID | K192595 |
| 510k Number | K192595 |
| Device Name: | ExSpiron 2Xi |
| Classification | Spirometer, Monitoring (w/wo Alarm) |
| Applicant | Respiratory Motion 80 Coolidge Hill Road Watertown, MA 02472 |
| Contact | Susan K. Hamann |
| Correspondent | Susan K. Hamann Respiratory Motion 80 Coolidge Hill Road Watertown, MA 02472 |
| Product Code | BZK |
| CFR Regulation Number | 868.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-20 |
| Decision Date | 2019-12-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851540007147 | K192595 | 000 |