JMS TRANSFUSION SET— 510(k) K880174

Name: FDA 510(k) clearance K880174
Creator: U.S. Food and Drug Administration
Published: 1988-02-16

Substantially Equivalent

Jms Co., Ltd.

FDA 510(k) clearance K880174 for JMS TRANSFUSION SET, Substantially Equivalent on 1988-02-16. Applicant: Jms Co., Ltd.. Device class: 2.

Clearance details

Applicant: Jms Co., Ltd.
Product code: Code BRZ
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1988-01-15
Decision date: 1988-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hiroshima, JP

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.