The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Modification To Airlife Heated Ventilator And Anesthesia Breathing Circuits.
| Device ID | K000697 |
| 510k Number | K000697 |
| Device Name: | MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS |
| Classification | Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| 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 | BZE |
| CFR Regulation Number | 868.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-01 |
| Decision Date | 2000-03-30 |