The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Auto-peep.
Device ID | K924043 |
510k Number | K924043 |
Device Name: | AUTO-PEEP |
Classification | Ventilator, Continuous, Facility Use |
Applicant | PURITAN BENNETT CORP. 2200 FARADAY AVE. Carlsbad, CA 92008 |
Contact | Paul Woodring |
Correspondent | Paul Woodring PURITAN BENNETT CORP. 2200 FARADAY AVE. Carlsbad, CA 92008 |
Product Code | CBK |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Se Subject To Tracking Reg (ST) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-11 |
Decision Date | 1994-09-22 |