Merits Health Products Portable Nebulizer
FDA 510(k) K053490 · Merits Health Products Co., Ltd.
510(k) numberK053490
Submission
- Device name
- Merits Health Products Portable Nebulizer
- Applicant
- Merits Health Products Co., Ltd.
Taichung, TW - Received
- December 15, 2005
- Decision date
- July 24, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 Merits Health Products Portable Nebulizer cleared by the FDA?
Merits Health Products Portable Nebulizer (K053490) received a 510(k) decision of Substantially Equivalent on July 24, 2006, 221 days after the submission was received.
What is the product code of K053490?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.