Galemed Neb-Easy Nebulizer
FDA 510(k) K021742 · Galemed Corp.
510(k) numberK021742
Submission
- Device name
- Galemed Neb-Easy Nebulizer
- Applicant
- Galemed Corp.
Temecula, CA, US - Received
- May 28, 2002
- Decision date
- October 25, 2002
- 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 Galemed Neb-Easy Nebulizer cleared by the FDA?
Galemed Neb-Easy Nebulizer (K021742) received a 510(k) decision of Substantially Equivalent on October 25, 2002, 150 days after the submission was received.
What is the product code of K021742?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.