K112859 is an FDA 510(k) clearance for the ERAPID NEBULIZER SYSTEM. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Pari Respiratory Equipment, Inc. (Midlothian, US). The FDA issued a Cleared decision on May 30, 2012, 243 days after receiving the submission on September 30, 2011.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K112859 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2011 |
| Decision Date | May 30, 2012 |
| Days to Decision | 243 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 |