GAMBRO PULSATILE MONITOR PLM 10-200— 510(k) K842503

Substantially Equivalent

Gambro, Inc.

FDA 510(k) clearance K842503 for GAMBRO PULSATILE MONITOR PLM 10-200, Substantially Equivalent on 1984-08-10. Applicant: Gambro, Inc..

Clearance details

Applicant: Gambro, Inc.
Product code: Code DWA
Advisory panel: Cardiovascular
Date received: 1984-06-26
Decision date: 1984-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DWA

product code DWA

Death: 15
Malfunction: 1,654
Total: 1,669

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.