The following data is part of a premarket notification filed by Puritan Bennett Corp. with the FDA for Humidifier-cascade Ii.
Device ID | K760923 |
510k Number | K760923 |
Device Name: | HUMIDIFIER-CASCADE II |
Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
Applicant | PURITAN BENNETT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BTT |
CFR Regulation Number | 868.5450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-10-28 |
Decision Date | 1976-11-19 |