The following data is part of a premarket notification filed by Automatic Liquid Packaging, Inc. with the FDA for Humidifier Adapter.
Device ID | K962079 |
510k Number | K962079 |
Device Name: | HUMIDIFIER ADAPTER |
Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
Applicant | AUTOMATIC LIQUID PACKAGING, INC. 2200 W. LAKE SHORE DR. Woodstock, IL 60098 |
Contact | John Brda |
Correspondent | John Brda AUTOMATIC LIQUID PACKAGING, INC. 2200 W. LAKE SHORE DR. Woodstock, IL 60098 |
Product Code | BTT |
CFR Regulation Number | 868.5450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-05-28 |
Decision Date | 1996-07-31 |