The following data is part of a premarket notification filed by Mallinckrodt Developpement France with the FDA for Goodknight H20, Model M-114600-00.
| Device ID | K042184 |
| 510k Number | K042184 |
| Device Name: | GOODKNIGHT H20, MODEL M-114600-00 |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | MALLINCKRODT DEVELOPPEMENT FRANCE 10 ALLEE PELLETIER DOISY Villers-les-nancy, FR 54601 |
| Contact | Moustafa Anki |
| Correspondent | Patricia Murphy KEMA QUALITY B.V. 4377 COUNTY LINE ROAD Chalfont, PA 18914 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-08-12 |
| Decision Date | 2005-01-10 |
| Summary: | summary |