K072466 is an FDA 510(k) clearance for the STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Scican , Ltd. (Toronto, CA). The FDA issued a Cleared decision on December 19, 2007, 106 days after receiving the submission on September 4, 2007.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K072466 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 2007 |
| Decision Date | December 19, 2007 |
| Days to Decision | 106 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 |