AirLife Misty Finity Nebulizer
FDA 510(k) K153748 · Care Fusion
510(k) numberK153748
Submission
- Device name
- AirLife Misty Finity Nebulizer
- Applicant
- Care Fusion
Vernon Hills, IL, US - Received
- December 29, 2015
- Decision date
- May 17, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 AirLife Misty Finity Nebulizer cleared by the FDA?
AirLife Misty Finity Nebulizer (K153748) received a 510(k) decision of Substantially Equivalent on May 17, 2017, 505 days after the submission was received.
What is the product code of K153748?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.