The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Puritan-bennett Model 7200ae Ventilator.
Device ID | K923809 |
510k Number | K923809 |
Device Name: | PURITAN-BENNETT MODEL 7200AE VENTILATOR |
Classification | Ventilator, Continuous, Facility Use |
Applicant | PURITAN BENNETT CORP. 2200 FARADAY AVE. Carlsbad, CA 92008 |
Contact | Mark Jensen |
Correspondent | Mark Jensen 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 | 1992-07-29 |
Decision Date | 1992-10-27 |