K021504 is an FDA 510(k) clearance for the TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540. 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 July 25, 2002, 77 days after receiving the submission on May 9, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K021504 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 2002 |
| Decision Date | July 25, 2002 |
| Days to Decision | 77 days |
| Submission Type | Abbreviated |
| 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 |