PUMP MODULES PMO LO-110-PMD 10-210— 510(k) K822071

Substantially Equivalent

Gambro, Inc.

FDA 510(k) clearance K822071 for PUMP MODULES PMO LO-110-PMD 10-210, Substantially Equivalent on 1982-08-24. Applicant: Gambro, Inc..

Clearance details

Applicant: Gambro, Inc.
Product code: Code DWB
Advisory panel: Cardiovascular
Date received: 1982-07-14
Decision date: 1982-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DWB

product code DWB

Death: 2
Total: 2

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.