K183444 is an FDA 510(k) clearance for the Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector. This device is classified as a Device, Pasteurization, Hot Water (Class II - Special Controls, product code LDS).
Submitted by Cenorin, LLC (Kent, US). The FDA issued a Cleared decision on September 9, 2019, 271 days after receiving the submission on December 12, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6991.
| 510(k) Number | K183444 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 2018 |
| Decision Date | September 09, 2019 |
| Days to Decision | 271 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | LDS - Device, Pasteurization, Hot Water |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6991 |