The following data is part of a premarket notification filed by Nellcor Puritan Bennett with the FDA for Puritan Bennett Legendair Xl2.
| Device ID | K070899 |
| 510k Number | K070899 |
| Device Name: | PURITAN BENNETT LEGENDAIR XL2 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | NELLCOR PURITAN BENNETT 4280 HACIENDA DR. Pleasanton, CA 94588 |
| Contact | James Bonds |
| Correspondent | James Bonds NELLCOR PURITAN BENNETT 4280 HACIENDA DR. Pleasanton, CA 94588 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-02 |
| Decision Date | 2007-12-13 |
| Summary: | summary |