The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Companion 2800 Volume Ventilator Remot Alarm.
| Device ID | K860675 |
| 510k Number | K860675 |
| Device Name: | COMPANION 2800 VOLUME VENTILATOR REMOT ALARM |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
| Contact | Hartley C Ericson |
| Correspondent | Hartley C Ericson PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-24 |
| Decision Date | 1986-04-07 |