The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Airlife Bubble Humidifer, Model 002003 And 002006.
| Device ID | K991484 |
| 510k Number | K991484 |
| Device Name: | AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006 |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park, IL 60085 |
| Contact | Sharon Robbins |
| Correspondent | Sharon Robbins ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD.- K Mcgraw Park, IL 60085 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-28 |
| Decision Date | 1999-05-13 |
| Summary: | summary |