The following data is part of a premarket notification filed by Cardinal Health with the FDA for Airlife Infant Nasal Continuous Positive Airway Pressure System.
| Device ID | K050994 |
| 510k Number | K050994 |
| Device Name: | AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | Cardinal Health 1430 WAUKEGAN RD. BUILDING KB Mcgaw Park, IL 60085 |
| Contact | Sharon Nichols |
| Correspondent | Sharon Nichols Cardinal Health 1430 WAUKEGAN RD. BUILDING KB Mcgaw Park, IL 60085 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-19 |
| Decision Date | 2005-08-03 |
| Summary: | summary |