K993856 is an FDA 510(k) clearance for the TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Tuttnauer U.S.A Co, Ltd. (Washington, US). The FDA issued a Cleared decision on February 9, 2001, 452 days after receiving the submission on November 15, 1999.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K993856 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 1999 |
| Decision Date | February 09, 2001 |
| Days to Decision | 452 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 |