Airlife Demand Nasal Cannula
FDA 510(k) K023673 · Allegiance Healthcare Corp.
510(k) numberK023673
Submission
- Device name
- Airlife Demand Nasal Cannula
- Applicant
- Allegiance Healthcare Corp.
Mcgaw Park, IL, US - Received
- November 1, 2002
- Decision date
- May 2, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NFB – Conserver, Oxygen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5905
- Specialty
- Anesthesiology
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| K022765 | Nitrile Powder-Free Examination GlovesLZA · Traditional | 10/11/2002SE |
| K023170 | Nitrile Powder-Free Examination GlovesLZA · Special | 10/09/2002SE |
| K023167 | Breathable Surgical GownFYA · Special | 10/02/2002SE |
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Questions and answers
When was Airlife Demand Nasal Cannula cleared by the FDA?
Airlife Demand Nasal Cannula (K023673) received a 510(k) decision of Substantially Equivalent on May 2, 2003, 182 days after the submission was received.
What is the product code of K023673?
The FDA product code is NFB – Conserver, Oxygen, a Class II (moderate risk) device regulated under 21 CFR 868.5905.