The following data is part of a premarket notification filed by Mallinckrodt Developpement France with the FDA for Mallinckrodt, Goodknight 418s.
| Device ID | K001845 |
| 510k Number | K001845 |
| Device Name: | MALLINCKRODT, GOODKNIGHT 418S |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | MALLINCKRODT DEVELOPPEMENT FRANCE 10 ALLEE PELLETIER DOISY Villers-les-nancy, FR 54601 |
| Contact | Moustafa Anki |
| Correspondent | Moustafa Anki MALLINCKRODT DEVELOPPEMENT FRANCE 10 ALLEE PELLETIER DOISY Villers-les-nancy, FR 54601 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-19 |
| Decision Date | 2000-07-05 |