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 |