The following data is part of a premarket notification filed by Mallinckrodt Developpement France with the FDA for Puritan Bennett, Sandman Duo And Sandman Duo St.
Device ID | K082237 |
510k Number | K082237 |
Device Name: | PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST |
Classification | Ventilator, Non-continuous (respirator) |
Applicant | MALLINCKRODT DEVELOPPEMENT FRANCE 6135 GUNBARREL AVE. Boulder, CO 80301 |
Contact | Tina Dreiling |
Correspondent | Tina Dreiling MALLINCKRODT DEVELOPPEMENT FRANCE 6135 GUNBARREL AVE. Boulder, CO 80301 |
Product Code | BZD |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-08-07 |
Decision Date | 2008-10-09 |
Summary: | summary |