The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Microprocessor 7200a Ventilator.
Device ID | K843424 |
510k Number | K843424 |
Device Name: | MICROPROCESSOR 7200A VENTILATOR |
Classification | Ventilator, Continuous, Facility Use |
Applicant | PURITAN BENNETT CORP. P.O. BOX 25905 Overland Park , KS 66225 - |
Contact | Hartley C Ericson |
Correspondent | Hartley C Ericson PURITAN BENNETT CORP. 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 | 1984-08-31 |
Decision Date | 1984-11-01 |