The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Infrasonics Adult Ventilator Trending Option.
| Device ID | K964543 |
| 510k Number | K964543 |
| Device Name: | INFRASONICS ADULT VENTILATOR TRENDING OPTION |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. Pleasanton, CA 94588 -2719 |
| Contact | Carole Miller |
| Correspondent | Carole Miller NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. Pleasanton, CA 94588 -2719 |
| 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 | 1996-11-13 |
| Decision Date | 1997-02-14 |
| Summary: | summary |