The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Companion 2800 Volume Ventilator Remote Alarm.
Device ID | K861488 |
510k Number | K861488 |
Device Name: | COMPANION 2800 VOLUME VENTILATOR REMOTE 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 | 1986-04-09 |
Decision Date | 1986-05-06 |