APPLICARD (EKG)— 510(k) K900459

Name: FDA 510(k) clearance K900459
Creator: U.S. Food and Drug Administration
Published: 1990-07-31

Substantially Equivalent

Medi-Globe Corp.

FDA 510(k) clearance K900459 for APPLICARD (EKG), Substantially Equivalent on 1990-07-31. Applicant: Medi-Globe Corp.. Device class: 2.

Clearance details

Applicant: Medi-Globe Corp.
Product code: Code DRY
Device class: Class 2
Regulation: 21 CFR 870.4330
Advisory panel: Cardiovascular
Date received: 1990-01-30
Decision date: 1990-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DRY

product code DRY

Death: 5
Total: 5

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.