The following data is part of a premarket notification filed by Belimed Ag with the FDA for Belimed Steam Sterilizer Mst-h Top 5000.
| Device ID | K191896 |
| 510k Number | K191896 |
| Device Name: | Belimed Steam Sterilizer MST-H TOP 5000 |
| Classification | Sterilizer, Steam |
| Applicant | Belimed AG Grienbachstrasse 11 Zug, CH 6300 |
| Contact | Marc Luthi |
| Correspondent | Marc Luthi Belimed AG Grienbachstrasse 11 Zug, CH 6300 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-15 |
| Decision Date | 2019-10-31 |
| Summary: | summary |