K170228 is an FDA 510(k) clearance for the Belimed Steam Sterilizer MST-H TOP 5000. This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Belimed AG (Zug, CH). The FDA issued a Cleared decision on May 12, 2017, 107 days after receiving the submission on January 25, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K170228 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 25, 2017 |
| Decision Date | May 12, 2017 |
| Days to Decision | 107 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 |