The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Model 7200a, Pressure Ventilation Option.
Device ID | K873151 |
510k Number | K873151 |
Device Name: | MODEL 7200A, PRESSURE VENTILATION OPTION |
Classification | Ventilator, Continuous, Facility Use |
Applicant | PURITAN BENNETT CORP. 9401 INDIAN CREEK PKWY. P.O. BOX 25905 Overland Park, KS 66225 |
Contact | Steven J Ojala |
Correspondent | Steven J Ojala 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 | 1987-08-11 |
Decision Date | 1988-05-31 |