Corrugated tube with mouthpiece accessory
FDA 510(k) K203400 · Trudell Medical International
510(k) numberK203400
Submission
- Device name
- Corrugated tube with mouthpiece accessory
- Applicant
- Trudell Medical International
London, CA - Received
- November 19, 2020
- Decision date
- June 14, 2021
- 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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| K173825 | MC 300R* NebulizerCAF · Traditional | 05/02/2018SE |
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Questions and answers
When was Corrugated tube with mouthpiece accessory cleared by the FDA?
Corrugated tube with mouthpiece accessory (K203400) received a 510(k) decision of Substantially Equivalent on June 14, 2021, 207 days after the submission was received.
What is the product code of K203400?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.