ELECTRONIC CONTROL UNIT— 510(k) K761087

Name: FDA 510(k) clearance K761087
Creator: U.S. Food and Drug Administration
Published: 1976-12-06

Substantially Equivalent

Gorman Rupp Industries

FDA 510(k) clearance K761087 for ELECTRONIC CONTROL UNIT, Substantially Equivalent on 1976-12-06. Applicant: Gorman Rupp Industries. Device class: 2.

Clearance details

Applicant: Gorman Rupp Industries
Product code: Code DWJ
Device class: Class 2
Regulation: 21 CFR 870.5900
Advisory panel: Cardiovascular
Date received: 1976-11-22
Decision date: 1976-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K771537 — AQUAMATIC K-MODULE MODEL K-201977-09-06
K770839 — AQUAMATIC K-771977-06-08
K770232 — BLOOD/FLUID WARMER MODEL DW-1000A1977-02-14
K761337 — AQUAMATIC K-MODULE MODEL K-101977-01-10
K760910 — DISPOSABLE K-PADS1976-12-16

Adverse events under product code DWJ

product code DWJ

Death: 7
Injury: 679
Malfunction: 17,477
Total: 18,163

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.