Belimed Steam Sterilizer MST-H TOP 5000— 510(k) K191896

Name: FDA 510(k) clearance K191896
Creator: U.S. Food and Drug Administration
Published: 2019-10-31

Substantially Equivalent

Belimed AG

FDA 510(k) clearance K191896 for Belimed Steam Sterilizer MST-H TOP 5000, Substantially Equivalent on 2019-10-31. Applicant: Belimed AG. Device class: 2.

Clearance details

Applicant: Belimed AG
Product code: Product code FLE
Device class: Class 2
Regulation: 21 CFR 880.6880
Advisory panel: General Hospital
Date received: 2019-07-15
Decision date: 2019-10-31
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Zug, CH

Download summary PDF View on FDA.gov ↗

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K170228 — Belimed Steam Sterilizer MST-H TOP 50002017-05-12

Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.