MULTISET 40— 510(k) K853386

Name: FDA 510(k) clearance K853386
Creator: U.S. Food and Drug Administration
Published: 1985-08-22

Substantially Equivalent

Migada, Ltd.

FDA 510(k) clearance K853386 for MULTISET 40, Substantially Equivalent on 1985-08-22. Applicant: Migada, Ltd.. Device class: 2.

Clearance details

Applicant: Migada, Ltd.
Product code: Code BRZ
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1985-08-12
Decision date: 1985-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Israel, IL

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BRZ

product code BRZ

Malfunction: 458
Total: 458

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.