R2(TM) ECG CABLE-ADAPTOR #'S 120-121-122— 510(k) K800931

Substantially Equivalent

R2 Corp.

FDA 510(k) clearance K800931 for R2(TM) ECG CABLE-ADAPTOR #'S 120-121-122, Substantially Equivalent on 1980-05-23. Applicant: R2 Corp..

Clearance details

Applicant: R2 Corp.
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 1980-04-21
Decision date: 1980-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DSA

product code DSA

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.