SOLUTION TRANSFER SET— 510(k) K834500

Substantially Equivalent

Berlex Laboratories, Inc.

FDA 510(k) clearance K834500 for SOLUTION TRANSFER SET, Substantially Equivalent on 1984-02-17. Applicant: Berlex Laboratories, Inc..

Clearance details

Applicant: Berlex Laboratories, Inc.
Product code: Code LHI
Advisory panel: General Hospital
Date received: 1983-12-21
Decision date: 1984-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.