R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS)— 510(k) K800935

Name: FDA 510(k) clearance K800935
Creator: U.S. Food and Drug Administration
Published: 1980-05-23

Substantially Equivalent

R2 Corp.

FDA 510(k) clearance K800935 for R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS), Substantially Equivalent on 1980-05-23. Applicant: R2 Corp.. Device class: 2.

Clearance details

Applicant: R2 Corp.
Product code: Code DRX
Device class: Class 2
Regulation: 21 CFR 870.2360
Advisory panel: Cardiovascular
Date received: 1980-04-21
Decision date: 1980-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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More clearances from R2 Corp.

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K832516 — MAGNATRODE CARDIAC MONITORING ELECTRODE1983-12-16
K800930 — R2(TM) ECG ELECTRODE SET-#'S305-306 ETC.1980-05-23
K800931 — R2(TM) ECG CABLE-ADAPTOR #'S 120-121-1221980-05-23
K800932 — ECG-RF-CHOKE CABLE-ADAPTER #'S 121,1201980-05-23
K800936 — R2 PADDLE TYPE CABLE-ADAPTOR #S 170,1711980-05-23

Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

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.