The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Ventilator With Respiratory Mechanics, Model 840.
| Device ID | K063650 |
| 510k Number | K063650 |
| Device Name: | VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | PURITAN BENNETT CORP. 5391 PRIESTLY DR., SUITE 100 Carlsbad, CA 92008 |
| Contact | Patrick Garvey |
| Correspondent | Patrick Garvey PURITAN BENNETT CORP. 5391 PRIESTLY DR., SUITE 100 Carlsbad, CA 92008 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-08 |
| Decision Date | 2007-02-15 |
| Summary: | summary |