The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Nellcor Puritan Bennett Gemini.
| Device ID | K972248 |
| 510k Number | K972248 |
| Device Name: | NELLCOR PURITAN BENNETT GEMINI |
| Classification | Ventilator, Continuous, Facility Use |
| 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 | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-16 |
| Decision Date | 1997-09-12 |
| Summary: | summary |