The following data is part of a premarket notification filed by Nellcor Puritan Bennett France Dvpt. with the FDA for Mallinckrodt, Goodknight 418a, Goodknight 418p, Silverlining 2.
| Device ID | K993584 |
| 510k Number | K993584 |
| Device Name: | MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2 |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | NELLCOR PURITAN BENNETT FRANCE DVPT. 10 ALLEE PELLETIER DOISY Villers-les-nancy, FR 54601 |
| Contact | Moustafa Anki |
| Correspondent | Moustafa Anki NELLCOR PURITAN BENNETT FRANCE DVPT. 10 ALLEE PELLETIER DOISY Villers-les-nancy, FR 54601 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-22 |
| Decision Date | 2000-03-07 |
| Summary: | summary |