K191896 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 October 31, 2019, 108 days after receiving the submission on July 15, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K191896 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 2019 |
| Decision Date | October 31, 2019 |
| Days to Decision | 108 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 |