The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Puritan-bennett 840 Ventilatory System With Bilevel Option.
| Device ID | K984535 |
| 510k Number | K984535 |
| Device Name: | PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | PURITAN BENNETT CORP. 2200 FARADAY AVE. Carlsbad, CA 92008 |
| Contact | Ann-marie Butler |
| Correspondent | Ann-marie Butler PURITAN BENNETT CORP. 2200 FARADAY AVE. Carlsbad, CA 92008 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-21 |
| Decision Date | 1998-12-28 |
| Summary: | summary |