The following data is part of a premarket notification filed by Allegiance Healthcare Corp. with the FDA for Airlife Demand Nasal Cannula.
| Device ID | K023673 |
| 510k Number | K023673 |
| Device Name: | AIRLIFE DEMAND NASAL CANNULA |
| Classification | Conserver, Oxygen |
| Applicant | ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD. MPWM-1E Mcgaw Park, IL 60085 |
| Contact | Sharon Nichols |
| Correspondent | Sharon Nichols ALLEGIANCE HEALTHCARE CORP. 1500 WAUKEGAN RD. MPWM-1E Mcgaw Park, IL 60085 |
| Product Code | NFB |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-01 |
| Decision Date | 2003-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30889483605800 | K023673 | 000 |
| 30889483605787 | K023673 | 000 |
| 30889483599550 | K023673 | 000 |