Small Volume Nebulizer
FDA 510(k) K023602 · Allegiance Healthcare Corporation
510(k) numberK023602
Submission
- Device name
- Small Volume Nebulizer
- Applicant
- Allegiance Healthcare Corporation
Mcgaw Park, IL, US - Received
- October 28, 2002
- Decision date
- May 1, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAF – Nebulizer (Direct Patient Interface)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5630
- Specialty
- Anesthesiology
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Questions and answers
When was Small Volume Nebulizer cleared by the FDA?
Small Volume Nebulizer (K023602) received a 510(k) decision of Substantially Equivalent on May 1, 2003, 185 days after the submission was received.
What is the product code of K023602?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.