The following data is part of a premarket notification filed by Fim Medical with the FDA for Q13 Spirolyser®.
| Device ID | K161676 |
| 510k Number | K161676 |
| Device Name: | Q13 SPIROLYSER® |
| Classification | Spirometer, Diagnostic |
| Applicant | FIM MEDICAL 51 RUE PRIMAT CS 60194 Villeurbanne Cedex , Rhone, FR 69625 |
| Contact | Liza Perrat |
| Correspondent | Daniel Kamm KAMM & ASSOCIATES 8870 RAVELLO CT Naples, FL 34114 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-17 |
| Decision Date | 2016-10-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760253450522 | K161676 | 000 |
| 03760253450010 | K161676 | 000 |
| 03760253450607 | K161676 | 000 |
| 03760253450577 | K161676 | 000 |
| 03760253450621 | K161676 | 000 |
| 03760253450614 | K161676 | 000 |
| 03760253450645 | K161676 | 000 |
| 03760253450638 | K161676 | 000 |