K122625 is an FDA 510(k) clearance for the GETINGE 800HC- SERIES STEAM STERILIZER. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Getinge Sourcing, LLC (Rochester, US). The FDA issued a Cleared decision on May 22, 2013, 267 days after receiving the submission on August 28, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K122625 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 2012 |
| Decision Date | May 22, 2013 |
| Days to Decision | 267 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 |