K111223 is an FDA 510(k) clearance for the AMSCO CHIMERON SMALL STEAM STERILIZER. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on September 20, 2011, 141 days after receiving the submission on May 2, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K111223 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2011 |
| Decision Date | September 20, 2011 |
| Days to Decision | 141 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FLE — Sterilizer, Steam |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6880 |