The following data is part of a premarket notification filed by Respiratory Motion, Inc. with the FDA for Exspiron 1xi.
| Device ID | K130170 |
| 510k Number | K130170 |
| 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 | Jenny Freeman, Md |
| Correspondent | Jenny Freeman, Md 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-24 |
| Decision Date | 2013-05-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851540007048 | K130170 | 000 |
| 00851540007024 | K130170 | 000 |
| 00851540007017 | K130170 | 000 |
| 00851540007000 | K130170 | 000 |