The following data is part of a premarket notification filed by Mallinckrodt Developpement France with the FDA for Goodknight 425, Modelm-114500-00.
| Device ID | K041819 |
| 510k Number | K041819 |
| Device Name: | GOODKNIGHT 425, MODELM-114500-00 |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | MALLINCKRODT DEVELOPPEMENT FRANCE 4280 HACIENDA DR. Pleasanton, CA 94588 |
| Contact | James Bonds |
| Correspondent | James Bonds MALLINCKRODT DEVELOPPEMENT FRANCE 4280 HACIENDA DR. Pleasanton, CA 94588 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-06 |
| Decision Date | 2004-07-22 |
| Summary: | summary |