The following data is part of a premarket notification filed by Fim Medical with the FDA for Spl-50 Spirolyser.
| Device ID | K010761 |
| 510k Number | K010761 |
| Device Name: | SPL-50 SPIROLYSER |
| Classification | Spirometer, Diagnostic |
| Applicant | FIM MEDICAL 30 RUE CAMILLE Lyon, FR 69003 |
| Contact | Eric Derei |
| Correspondent | Eric Derei FIM MEDICAL 30 RUE CAMILLE Lyon, FR 69003 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-13 |
| Decision Date | 2002-03-05 |