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 |