K161848 is an FDA 510(k) clearance for the Family of Steam sterilizers B17 B22 Series. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Cefla S.C. (Imola (Bo), IT). The FDA issued a Cleared decision on February 23, 2017, 233 days after receiving the submission on July 5, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K161848 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2016 |
| Decision Date | February 23, 2017 |
| Days to Decision | 233 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 |