The following data is part of a premarket notification filed by Tyco Healthcare Nancy with the FDA for Puritan Bennett, Goodknight 420 Evolution, Model M-113903-us.
| Device ID | K031470 |
| 510k Number | K031470 |
| Device Name: | PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | TYCO HEALTHCARE NANCY NELLCOR PURITAN BENNETT DIV. 4280 HACIENDA DRIVE Pleasanton, CA 94588 |
| Contact | James Bonds |
| Correspondent | James Bonds TYCO HEALTHCARE NANCY NELLCOR PURITAN BENNETT DIV. 4280 HACIENDA DRIVE Pleasanton, CA 94588 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-09 |
| Decision Date | 2003-06-05 |
| Summary: | summary |