MEDISYSTEM NEGATIVE PRESSURE— 510(k) K811839

Name: FDA 510(k) clearance K811839
Creator: U.S. Food and Drug Administration
Published: 1981-09-08

Substantially Equivalent

Medisystems Corp.

FDA 510(k) clearance K811839 for MEDISYSTEM NEGATIVE PRESSURE, Substantially Equivalent on 1981-09-08. Applicant: Medisystems Corp.. Device class: 2.

Clearance details

Applicant: Medisystems Corp.
Product code: Code FJK
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1981-07-01
Decision date: 1981-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FJK

product code FJK

Death: 52
Malfunction: 3,430
Total: 3,482

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.