K112055 is an FDA 510(k) clearance for the AMSCO CHIMERON MEDIUM 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 December 16, 2011, 150 days after receiving the submission on July 19, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K112055 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 2011 |
| Decision Date | December 16, 2011 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| 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 |