The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Microprocessor Ventilator 7200.
Device ID | K833786 |
510k Number | K833786 |
Device Name: | MICROPROCESSOR VENTILATOR 7200 |
Classification | Ventilator, Continuous, Facility Use |
Applicant | PURITAN BENNETT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CBK |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-10-28 |
Decision Date | 1983-12-22 |