K181456 is an FDA 510(k) clearance for the Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Tuttnauer , Ltd. (Beit Shemesh, IL). The FDA issued a Cleared decision on July 8, 2019, 399 days after receiving the submission on June 4, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K181456 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 2018 |
| Decision Date | July 08, 2019 |
| Days to Decision | 399 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FLE - Sterilizer, Steam |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6880 |