The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Goodknight 418 Cpap System.
| Device ID | K980365 |
| 510k Number | K980365 |
| Device Name: | GOODKNIGHT 418 CPAP SYSTEM |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | NELLCOR PURITAN BENNETT, INC. 2800 NORTHWEST BLVD. Minneapolis, MN 55441 -2625 |
| Contact | Stephen Theissen |
| Correspondent | Stephen Theissen NELLCOR PURITAN BENNETT, INC. 2800 NORTHWEST BLVD. Minneapolis, MN 55441 -2625 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-29 |
| Decision Date | 1998-07-22 |
| Summary: | summary |