BLOOD/FLUID WARMER MODEL DW-1000A— 510(k) K770232

Substantially Equivalent

Gorman Rupp Industries

FDA 510(k) clearance K770232 for BLOOD/FLUID WARMER MODEL DW-1000A, Substantially Equivalent on 1977-02-14. Applicant: Gorman Rupp Industries.

Clearance details

Applicant: Gorman Rupp Industries
Product code: Code BSB
Advisory panel: Hematology
Date received: 1977-02-07
Decision date: 1977-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code BSB

product code BSB

Death: 5
Malfunction: 1,778
Total: 1,783

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.