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 |