K060811 is an FDA 510(k) clearance for the OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Omron Healthcare, Inc. (Mccordsville, US). The FDA issued a Cleared decision on May 25, 2006, 62 days after receiving the submission on March 24, 2006.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K060811 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 2006 |
| Decision Date | May 25, 2006 |
| Days to Decision | 62 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 |