DISPOSABLE BAG DECANTER— 510(k) K934179

Substantially Equivalent

Byron Medical

FDA 510(k) clearance K934179 for DISPOSABLE BAG DECANTER, Substantially Equivalent on 1994-05-23. Applicant: Byron Medical.

Clearance details

Applicant: Byron Medical
Product code: Code KPE
Advisory panel: General Hospital
Date received: 1993-08-26
Decision date: 1994-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

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Adverse events under product code KPE

product code KPE

Malfunction: 1,000
Other: 1
Total: 1,001

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.