The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Airlife Hepa Filter.
| Device ID | K011132 |
| 510k Number | K011132 |
| Device Name: | AIRLIFE HEPA FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| 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 | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-13 |
| Decision Date | 2001-06-08 |