The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Puritan-bennett Ventilator System With Et/tracheostomy Tube Compensation, Tc, Option, Model 840.
| Device ID | K993071 |
| 510k Number | K993071 |
| Device Name: | PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | PURITAN BENNETT CORP. 2200 FARADAY AVE. Carlsbad, CA 92008 |
| Contact | Delton West |
| Correspondent | Delton West 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 | 1999-09-14 |
| Decision Date | 1999-11-24 |
| Summary: | summary |