The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Puritan-bennett Companion 2801 Volume Ventilator.
Device ID | K897113 |
510k Number | K897113 |
Device Name: | PURITAN-BENNETT COMPANION 2801 VOLUME VENTILATOR |
Classification | Ventilator, Continuous, Facility Use |
Applicant | PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
Contact | Marshall Smith |
Correspondent | Marshall Smith 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 | 1989-12-26 |
Decision Date | 1990-03-26 |