The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Model 840 Ventilator With Proportional Assist Ventilation Plus Software Option.
| Device ID | K053388 |
| 510k Number | K053388 |
| Device Name: | MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | PURITAN BENNETT CORP. 4280 HACIENDA DR. Pleasanton, CA 94588 -2719 |
| Contact | James Bonds |
| Correspondent | James Bonds PURITAN BENNETT CORP. 4280 HACIENDA DR. Pleasanton, CA 94588 -2719 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-05 |
| Decision Date | 2006-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521641013 | K053388 | 000 |