The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Model 7200ae Ventilator Flow By 2.0 Or Option 50.
| Device ID | K920002 |
| 510k Number | K920002 |
| Device Name: | MODEL 7200AE VENTILATOR FLOW BY 2.0 OR OPTION 50 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | PURITAN BENNETT CORP. 2200 FARADAY AVE. Carlsbad, CA 92008 |
| Contact | Stephan Norsted |
| Correspondent | Stephan Norsted PURITAN BENNETT CORP. 2200 FARADAY AVE. Carlsbad, CA 92008 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-02 |
| Decision Date | 1992-11-10 |