K090265 is an FDA 510(k) clearance for the BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V. 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 May 15, 2009, 101 days after receiving the submission on February 3, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K090265 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 2009 |
| Decision Date | May 15, 2009 |
| Days to Decision | 101 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 |