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 |