K143311 is an FDA 510(k) clearance for the Pre-vacuum Tabletop Autoclave. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Tuttnauer U.S.A Co, Ltd. (Hauppauge, US). The FDA issued a Cleared decision on January 15, 2015, 58 days after receiving the submission on November 18, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K143311 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 2014 |
| Decision Date | January 15, 2015 |
| Days to Decision | 58 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 |