MC 300R* Nebulizer
FDA 510(k) K173825 · Trudell Medical International
510(k) numberK173825
Submission
- Device name
- MC 300R* Nebulizer
- Applicant
- Trudell Medical International
London, CA - Received
- December 18, 2017
- Decision date
- May 2, 2018
- 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 MC 300R* Nebulizer cleared by the FDA?
MC 300R* Nebulizer (K173825) received a 510(k) decision of Substantially Equivalent on May 2, 2018, 135 days after the submission was received.
What is the product code of K173825?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.