Compressor Nebulizer, Model Emg NBA02-XXX Series
FDA 510(k) K043238 · Emg Technology Co., Ltd.
510(k) numberK043238
Submission
- Device name
- Compressor Nebulizer, Model Emg NBA02-XXX Series
- Applicant
- Emg Technology Co., Ltd.
Baltimore, MD, US - Received
- November 22, 2004
- Decision date
- July 6, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement 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 Compressor Nebulizer, Model Emg NBA02-XXX Series cleared by the FDA?
Compressor Nebulizer, Model Emg NBA02-XXX Series (K043238) received a 510(k) decision of Substantially Equivalent on July 6, 2005, 226 days after the submission was received.
What is the product code of K043238?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.