APPLICARD SYSTEM (ECG ELECTRODE SYSTEM)— 510(k) K864260

Name: FDA 510(k) clearance K864260
Creator: U.S. Food and Drug Administration
Published: 1987-05-11

Substantially Equivalent

Grandcor Medical Systems

FDA 510(k) clearance K864260 for APPLICARD SYSTEM (ECG ELECTRODE SYSTEM), Substantially Equivalent on 1987-05-11. Applicant: Grandcor Medical Systems. Device class: 2.

Clearance details

Applicant: Grandcor Medical Systems
Product code: Code DRX
Device class: Class 2
Regulation: 21 CFR 870.2360
Advisory panel: Cardiovascular
Date received: 1986-10-29
Decision date: 1987-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dayton, OH, US

Download summary PDF View on FDA.gov ↗

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More clearances from Grandcor Medical Systems

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K905480 — SPIROSCOPE1991-05-06
K895547 — GRANDCOR/CARDIOLINE ECT STRESS TESTING1990-03-13
K883410 — CARDIOMEGA-T1988-10-17
K871890 — CARDIO-MEGA SYSTEM1987-06-12
K864978 — APPLISCOPE1987-02-19

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.