K801015

Substantially Equivalent

PREZAPAK L ARTERIAL BLOOD SAMPLING KIT

Applicant: Kimble-Terumo, Inc.
Product code: GIM
Advisory panel: Clinical Chemistry
Date received: 1980-04-29
Decision date: 1980-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Adverse events under product code GIM

product code GIM

Malfunction: 1,325
Total: 1,325

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.