The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Goodknight 425st.
| Device ID | K050072 |
| 510k Number | K050072 |
| Device Name: | GOODKNIGHT 425ST |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. Pleasanton, CA 94588 -2719 |
| Contact | James Bonds |
| Correspondent | James Bonds NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. Pleasanton, CA 94588 -2719 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-12 |
| Decision Date | 2005-06-13 |
| Summary: | summary |