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 |