The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Morphee Plus Alpha.
| Device ID | K964019 |
| 510k Number | K964019 |
| Device Name: | MORPHEE PLUS ALPHA |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | NELLCOR PURITAN BENNETT, INC. 10200 VALLEY VIEW RD. Eden Prairie, MN 55344 |
| Contact | Chris Hadland |
| Correspondent | Chris Hadland NELLCOR PURITAN BENNETT, INC. 10200 VALLEY VIEW RD. Eden Prairie, MN 55344 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-07 |
| Decision Date | 1997-06-18 |
| Summary: | summary |