Hudson RCI AquaPak Sterile Prefilled Nebulizers
FDA 510(k) K153010 · Teleflexmedical, Inc.
510(k) numberK153010
Submission
- Device name
- Hudson RCI AquaPak Sterile Prefilled Nebulizers
- Applicant
- Teleflexmedical, Inc.
Morrisville, NC, US - Received
- October 14, 2015
- Decision date
- July 26, 2016
- 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 Hudson RCI AquaPak Sterile Prefilled Nebulizers cleared by the FDA?
Hudson RCI AquaPak Sterile Prefilled Nebulizers (K153010) received a 510(k) decision of Substantially Equivalent on July 26, 2016, 286 days after the submission was received.
What is the product code of K153010?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.