MSI PRESSURE INFUSOR— 510(k) K973843

Substantially Equivalent

Smith Assoc.

FDA 510(k) clearance K973843 for MSI PRESSURE INFUSOR, Substantially Equivalent on 1997-10-29. Applicant: Smith Assoc..

Clearance details

Applicant: Smith Assoc.
Product code: Code KZD
Advisory panel: General Hospital
Date received: 1997-10-08
Decision date: 1997-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crofton, MD, US

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Adverse events under product code KZD

product code KZD

Death: 4
Total: 4

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.