Emg Handle Nebulizer NB02 Series
FDA 510(k) K052438 · Emg Technology Co., Ltd.
510(k) numberK052438
Submission
- Device name
- Emg Handle Nebulizer NB02 Series
- Applicant
- Emg Technology Co., Ltd.
Wilkes Barre, PA, US - Received
- September 6, 2005
- Decision date
- January 31, 2006
- 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 Emg Handle Nebulizer NB02 Series cleared by the FDA?
Emg Handle Nebulizer NB02 Series (K052438) received a 510(k) decision of Substantially Equivalent on January 31, 2006, 147 days after the submission was received.
What is the product code of K052438?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.