The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Ventnet; Central Monitoring Station.
| Device ID | K963633 |
| 510k Number | K963633 |
| Device Name: | VENTNET; CENTRAL MONITORING STATION |
| Classification | Accessory To Continuous Ventilator (respirator) |
| Applicant | PURITAN BENNETT CORP. 15222 DEL AMO AVE. Tustin, CA 92780 |
| Contact | Ray Pizinger |
| Correspondent | Ray Pizinger PURITAN BENNETT CORP. 15222 DEL AMO AVE. Tustin, CA 92780 |
| Product Code | MOD |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-11 |
| Decision Date | 1996-12-16 |
| Summary: | summary |