The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Nellcor Puritan Bennett Achieva Ventilator And Report Generator.
| Device ID | K990177 |
| 510k Number | K990177 |
| Device Name: | NELLCOR PURITAN BENNETT ACHIEVA VENTILATOR AND REPORT GENERATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | NELLCOR PURITAN BENNETT, INC. 2800 NORTHWEST BLVD. Minneapolis, MN 55441 -2625 |
| Contact | Cheryl Rosenberg |
| Correspondent | Cheryl Rosenberg NELLCOR PURITAN BENNETT, INC. 2800 NORTHWEST BLVD. Minneapolis, MN 55441 -2625 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-19 |
| Decision Date | 1999-11-18 |
| Summary: | summary |