Newport Nebsonic N550 Ultrasonic Nebulizer
FDA 510(k) K041082 · Newport Medical Instruments, Inc.
510(k) numberK041082
Submission
- Device name
- Newport Nebsonic N550 Ultrasonic Nebulizer
- Applicant
- Newport Medical Instruments, Inc.
Costa Mesa, CA, US - Received
- April 26, 2004
- Decision date
- September 7, 2004
- 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 Newport Nebsonic N550 Ultrasonic Nebulizer cleared by the FDA?
Newport Nebsonic N550 Ultrasonic Nebulizer (K041082) received a 510(k) decision of Substantially Equivalent on September 7, 2004, 134 days after the submission was received.
What is the product code of K041082?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.