K153010 is an FDA 510(k) clearance for the Hudson RCI AquaPak Sterile Prefilled Nebulizers. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Teleflexmedical, Inc. (Morrisville, US). The FDA issued a Cleared decision on July 26, 2016, 286 days after receiving the submission on October 14, 2015.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K153010 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 2015 |
| Decision Date | July 26, 2016 |
| Days to Decision | 286 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAF — Nebulizer (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5630 |